Biosimilar

Last updated

A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. [1] Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. [2] Reference to the innovator product is an integral component of the approval. [3]

Contents

Unlike with generic drugs of the more common small-molecule type, biosimilar drugs generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite this heterogeneity, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle. [4]

Drug-related authorities such as the European Medicines Agency (EMA) of the European Union, the United States Food and Drug Administration (FDA), and the Health Products and Food Branch of Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies demonstrate that the biological product is highly similar to the reference product, despite minor differences in clinically inactive components, animal studies (including the assessment of toxicity), and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics). They are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and is intended to be used and for which licensure is sought for the biological product.[ citation needed ]

The World Health Organization (WHO) published its "Guidelines for the evaluation of similar biotherapeutic products (SBPs)" in 2009. The purpose of this guideline is to provide an international norm for evaluating biosimilars. [5] [6] [7] [8]

The EMA has granted marketing authorizations for more than 50 biosimilars since 2006. The first biosimilar of a monoclonal antibody to be approved worldwide was a biosimilar of infliximab in the EU in 2013. [9] On March 6, 2015, the FDA approved the United States' first biosimilar product, the biosimilar of filgrastim called filgrastim-sndz (trade name Zarxio) by Sandoz.

Approval processes

United States

In the United States, the Food and Drug Administration (FDA) held that new legislation was required to enable them to approve biosimilars to those biologics originally approved through the PHS Act pathway. [10] Additional Congressional hearings have been held. [11] On March 17, 2009, the Pathway for Biosimilars Act was introduced in the House. [2] Since 2004 the FDA has held a series of public meetings on biosimilars. [12] [13]

The FDA gained the authority to approve biosimilars (including interchangeables that are substitutable with their reference product) as part of the Patient Protection and Affordable Care Act signed into law by President Obama on March 23, 2010.[ citation needed ]

The FDA has previously approved biologic products using comparability, for example, Omnitrope in May 2006, but this like Enoxaparin was also to a reference product, Genotropin, originally approved as a biologic under the FD&C Act. [14]

On March 6, 2015, Zarxio obtained the first approval of FDA. [15] Sandoz's Zarxio is biosimilar to Amgen's Neupogen (filgrastim), which was originally licensed in 1991. This is the first product to be passed under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was passed as part of the Affordable Healthcare Act. But Zarxio was approved as a biosimilar, not as an interchangeable product, the FDA notes. And under the BPCI Act, only a biologic that has been approved as an "interchangeable" may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. The FDA said its approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen.[ citation needed ]

In March 2020, most protein products that were approved as drug products (including every insulin currently on the market as of December 2019) are scheduled to open up to biosimilar and interchangeable competition in the United States. [16] However, "chemically synthesized polypeptides" are excluded from this transition, which means that a product that falls within this category won't be able to come to market as a biosimilar or interchangeable product, but will have to come to the market under a different pathway. [16]

Background

Cloning of human genetic material and development of in vitro biological production systems has allowed the production of virtually any recombinant DNA based biological substance for eventual development of a drug. Monoclonal antibody technology combined with recombinant DNA technology has paved the way for tailor-made and targeted medicines. Gene- and cell-based therapies are emerging as new approaches.

Recombinant therapeutic proteins are of a complex nature (composed of a long chain of amino acids, modified amino acids, derivatized by sugar moieties, folded by complex mechanisms). These proteins are made in living cells (bacteria, yeast, animal or human cell lines). The ultimate characteristics of a drug containing a recombinant therapeutic protein are to a large part determined by the process through which they are produced: choice of the cell type, development of the genetically modified cell for production, production process, purification process, formulation of the therapeutic protein into a drug.

After the expiry of the patent of approved recombinant drugs (e.g., insulin, human growth hormone, interferons, erythropoietin, monoclonal antibodies and more) any other biotech company can develop and market these biologics (thus called biosimilars).

The typical reference product has undergone numerous changes in its manufacturing processes, and such changes in the manufacturing process (ranging from a change in the supplier of cell culture media to new purification methods or new manufacturing sites) was substantiated with appropriate data and was approved by the EMA.

The current concept of development of biosimilar monoclonal antibodies follows the principle that an extensive state of the art physicochemical, analytical and functional comparison of the molecules is complemented by comparative non-clinical and clinical data that establish equivalent efficacy and safety in a clinical "model" indication that is most sensitive to detect any minor differences (if these exist) between the biosimilar and its reference monoclonal antibody also at the clinical level.

The EMA has recognized this fact, which has resulted in the establishment of the term "biosimilar" in recognition that, whilst biosimilar products are similar to the original product, they are not exactly the same. [17]

Originally the complexity of biological molecules led to requests for substantial efficacy and safety data for a biosimilar approval. This has been progressively replaced with a greater dependence on assays, from quality through to clinical, that show assay sensitivity sufficient to detect any significant difference in dose. [18] However, the safe application of biologics depends on an informed and appropriate use by healthcare professionals and patients. Introduction of biosimilars also requires a specifically designed pharmacovigilance plan. It is difficult and costly to recreate biologics because the complex proteins are derived from living organisms that are genetically modified. In contrast, small molecule drugs made up of a chemically based compound can be easily replicated and are considerably less expensive to reproduce. In order to be released to the public, biosimilars must be shown to be as close to identical to the parent innovator biologic product based on data compiled through clinical, animal, analytical studies and conformational status. [19] [20]

Generally, once a drug is released in the market by the FDA, it has to be re-evaluated for its safety and efficacy once every six months for the first and second years. Afterward, re-evaluations are conducted yearly, and the result of the assessment should be reported to authorities such as FDA. Biosimilars are required to undergo pharmacovigilance (PVG) regulations as its reference product. Thus biosimilars approved by the EMA are required to submit a risk management plan (RMP) along with the marketing application and have to provide regular safety update reports after the product is in the market. The RMP includes the safety profile of the drug and proposes the prospective pharmacovigilance studies.

Several PK studies, such as studies conducted by Committee for Medicinal Products for Human Use (CHMP), have been conducted under various ranges of conditions; Antibodies from an originator's product versus antibodies from a biosimilar; combination therapy and monotherapy; various diseases, etc. on the purpose to verify comparability in pharmacokinetics of the biosimilar with the reference medicinal product in a sufficiently sensitive and homogeneous population.

Nomenclature

In the European Union, no unique identifier of a biosimilar medicine product is required, as the same rules are followed as for all biologics.[ citation needed ]

The US decided on a different approach, requiring the assignment of a four-letter suffix to the nonproprietary name of the original product to distinguish between innovator drugs and their biosimilars. [21] Japan has similar requirements. [22] The suffix approach has been criticized on the grounds of compromising the INN system and delaying the marketing of biosimilars. [22] Australia decided not to use a 4-letter suffix. [23] [24] [25]

A version of the four-letter suffix has been proposed to the WHO as the biological qualifier (BQ). It is not part of the international nonproprietary name (INN), but is proposed to be managed under the same registry. [26] The report 1 of the May 2017 WHO Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products, published in October 2017, revealed on page 4, that following the outcome arising from the meeting: "No consensus was reached on whether WHO should continue with the BQ... WHO will not be proceeding with this at present." [27]

Australia

Biosimilars available in Australia include adalimumab, bevacizumab, enoxaparin, epoetin lambda, etanercept, filgrastim, follitropin alfa, infliximab, insulin aspart, insulin glargine, pegfilgrastim, rituximab, teriparatide, and trastuzumab. [28]

Egypt

A research article about "Maximizing the benefits of using biosimilars in Egypt" proposed a regulatory framework for biosimilars in Egypt. The article summarized the recommendations of a number of stakeholders. [29]

Key Findings and Recommendations of the article
  1. Pricing: The experts suggested a mandatory discount of 30–40% on the price of the first biosimilar compared to its originator, with subsequent biosimilars receiving additional discounts. It was also recommended that biosimilar prices be revised periodically, either annually or biennially.
  2. Reimbursement: A significant emphasis was placed on using Health Technology Assessment (HTA), specifically cost-effectiveness analysis (CEA) and budget impact analysis (BIA), when manufacturers seek to extend reimbursement indications beyond those of the originator. Additionally, experts proposed that the first biosimilar, offering a minimum 50% discount compared to the originator, be granted immunity from removal from the formulary for a specified period.
  3. Uptake: The study highlighted the need for policies that enhance both prescriber and patient acceptance of biosimilars. Strategies include disseminating educational materials, implementing financial incentives for prescribing biosimilars as first-line therapy, and using co-payments to encourage the choice of less expensive biosimilars over more costly biologics.
  4. Post-Marketing and Pharmacovigilance: The importance of establishing registries and conducting real-world evidence studies to monitor biosimilar efficacy and safety was also emphasized. A pharmacovigilance framework specific to biosimilars and biologics was suggested to be more effective than the existing general framework.

European Union

Biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar. [30]

European Union approved biosimilars [31]
Active substanceReference productBiosimilar medicines
Adalimumab Humira [32] Amgevita, [33] Amsparity, [34] Cyltezo, [35] Halimatoz, [36] Hefiya, [37] Hukyndra, [38] Hulio, [39] Hyrimoz, [40] Idacio, [41] Imraldi, [42] Kromeya, [43] Libmyris, [44] Solymbic, [45] Trudexa, [46] Yuflyma [47]
Bevacizumab Avastin [48] Abevmy, [49] Alymsys, [50] Aybintio, [51] Equidacent, [52] Mvasi, [53] Onbevzi, [54] Oyavas, [55] Vegzelma, [56] Zirabev [57]
Enoxaparin sodium Clexane [58] Inhixa, [58] Thorinane [59]
Epoetin alfa Eprex/ErypoAbseamed, [60] Binocrit, [61] Epoetin Alfa Hexal, [62] Retacrit, [63] Silapo [64]
Etanercept Enbrel [65] Benepali, [66] Erelzi, [67] Lifmior, [68] Nepexto [69]
Filgrastim Neupogen [70] Accofil, [71] Biograstim, [72] Filgrastim Hexal, [73] Filgrastim ratiopharm, [74] Grastofil, [75] Nivestim, [70] Ratiograstim, [76] Tevagrastim, [77] Zarzio [78]
Follitropin alfa Gonal-F [79] Bemfola, [80] Ovaleap [81]
Infliximab Remicade [82] Flixabi, [83] Inflectra, [84] Remsima, [85] Zessly [86]
Insulin aspart NovoRapid [87] Fiasp, [88] Insulin aspart Sanofi, [89] Kirsty, [90] NovoMix, [91] Ryzodeg [92]
Insulin glargine Lantus [93] Abasaglar, [94] Semglee [95]
Insulin lispro Humalog [96] Insulin lispro Sanofi [97]
Pegfilgrastim Neulasta [98] Cegfila, [99] Fulphila, [100] Grasustek, [101] Pelgraz, [102] Pelmeg, [103] Udenyca, [104] Stimufend, [105] Ziextenzo [106]
Ranibizumab Lucentis [107] Byooviz, [108] Ranivisio, [109] Ximluci [110]
Rituximab MabThera [111] Blitzima, [112] Ritemvia, [113] Rituzena, [114] Rixathon, [115] Riximyo, [116] Ruxience, [117] Truxima [118]
Somatropin Genotropin [119] Omnitrope [119]
Teriparatide Forsteo [120] Movymia, [121] Terrosa [122]
Tocilizumab RoActemra [123] Tyenne [124]
Trastuzumab Herceptin [125] Herzuma, [126] Kanjinti, [127] Ogivri, [128] Ontruzant, [129] Trazimera, [130] Zercepac [131]

United States

As of October 2024, the US FDA has approved 60 biosimilars. [132] [133]

BPCI Act

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was originally sponsored and introduced on June 26, 2007, by Senator Edward Kennedy (D-MA). It was formally passed under the Patient Protection and Affordable Care Act (PPAC Act), signed into law by President Barack Obama on March 23, 2010. The BPCI Act was an amendment to the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to a Food and Drug Administration (FDA) approved biological product. [134] The BPCI Act is similar, conceptually, to the Drug Price Competition and Patent Term Restoration Act of 1984 (also referred to as the "Hatch-Waxman Act") which created biological drug approval through the Federal Food, Drug, and Cosmetic Act (FFD&C Act). The BPCI Act aligns with the FDA's longstanding policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing. The FDA has released a total of four draft guidelines related to biosimilar or follow-on biologics development. Upon the release of the first three guidance documents the FDA held a public hearing on May 11, 2012. [135]

In 2018, the FDA released a Biosimilars Action Plan to implement regulations from the BPCI, including limiting the abuse of the Risk Evaluation and Mitigation Strategy (REMS) system for evergreening and transitioning insulin and human growth hormone to regulation as biologics rather than drugs. [136]

US approved biosimilars

Date of Biosimilar FDA ApprovalBiosimilar Product [132] Original Product [132]
March 2015 [137] filgrastim-sndz/Zarxio filgrastim/Neupogen
April 2016 [138] infliximab-dyyb/Inflectra infliximab/Remicade
August 2016 [139] [140] etanercept-szzs/Erelzi etanercept/Enbrel
September 2016 [141] [142] adalimumab-atto/Amjevita adalimumab/Humira
April 2017 [143] infliximab-abda/Renflexis infliximab/Remicade
August 2017 [144] adalimumab-adbm/Cyltezo adalimumab/Humira
September 2017 [145] [146] bevacizumab-awwb/Mvasi bevacizumab/Avastin
December 2017 [147] [148] trastuzumab-dkst/Ogivri trastuzumab/Herceptin
December 2017 [149] infliximab-qbtx/Ixifi infliximab/Remicade
May 2018 [150] [151] epoetin alfa-epbx/Retacrit epoetin alfa/Procrit
June 2018 [152] [153] pegfilgrastim-jmdb/Fulphila pegfilgrastim/Neulasta
July 2018 [154] filgrastim-aafi/Nivestym filgrastim/Neupogen
October 2018 [155] adalimumab-adaz/Hyrimoz adalimumab/Humira
November 2018 [156] pegfilgrastim-cbqv/Udenyca pegfilgrastim/Neulasta
November 2018 [157] rituximab-abbs/Truxima rituximab/Rituxan
December 2018 [158] trastuzumab-pkrb/Herzuma trastuzumab/Herceptin
January 2019 [159] trastuzumab-dttb/Ontruzant trastuzumab/Herceptin
March 2019 [160] trastuzumab-qyyp/Trazimera trastuzumab/Herceptin
April 2019 [161] etanercept-ykro/Eticovo etanercept/Enbrel
June 2019 [162] trastuzumab-anns/Kanjinti trastuzumab/Herceptin
June 2019 [163] bevacizumab-bvzr/Zirabev bevacizumab/Avastin
July 2019 [164] rituximab-pvvr/Ruxience rituximab/Rituxan
July 2019 [165] adalimumab-bwwd/Hadlima adalimumab/Humira
November 2019 [166] pegfilgrastim-bmez/Ziextenzo pegfilgrastim/Neulasta
November 2019 [167] adalimumab-afzb/Abrilada adalimumab/Humira
December 2019 [168] infliximab-axxq/Avsola infliximab/Remicade
June 2020 [169] pegfilgrastim-apgf/Nyvepria pegfilgrastim/Neulasta
July 2020 [170] adalimumab-fkjp/Hulio adalimumab/Humira
December 2020 [171] rituximab-arrx/Riabni rituximab/Rituxan
July 2021 [172] insulin glargine-yfgn/Semglee insulin glargine/Lantus
September 2021 [173] ranibizumab-nuna/Byooviz ranibizumab/Lucentis
December 2021 [174] insulin glargine-aglr/Rezvoglar insulin glargine/Lantus
December 2021 [175] adalimumab-aqvh/Yusimry adalimumab/Humira
February 2022 [176] filgrastim-ayow/Releuko filgrastim/Neupogen
April 2022 [177] bevacizumab-maly/Alymsys bevacizumab/Avastin
May 2022 [178] pegfilgrastim-pbbk/Fylnetra pegfilgrastim/Neulasta
August 2022 [179] ranibizumab-eqrn/Cimerli ranibizumab/Lucentis
September 2022 [180] pegfilgrastim-fpgk/Stimufend pegfilgrastim/Neulasta
September 2022 [181] bevacizumab-adcd/Vegzelma bevacizumab/Avastin
December 2022 [182] adalimumab-aacf/Idacio adalimumab/Humira
May 2023 [183] adalimumab-aaty/Yuflyma adalimumab/Humira
August 2023 [184] natalizumab-sztn/Tyruko natalizumab/Tysabri
September 2023 [185] tocilizumab-bavi/Tofidence tocilizumab/Actemra
October 2023 [186] ustekinumab-auub/Wezlana ustekinumab/Stelara
December 2023 [132] bevacizumab-tnjn/Avzivi bevacizumab/Avastin
February 2024 [132] adalimumab-ryvk/Simlandi adalimumab/Humira
March 2024 [132] denosumab-bbdz/Jubbonti denosumab/Prolia
March 2024 [132] denosumab-bbdz/Wyost denosumab/Xgeva
March 2024 [132] tocilizumab-aazg/Tyenne tocilizumab/Actemra
April 2024 [132] ustekinumab-aekn/Selarsdi ustekinumab/Stelara
April 2024 [132] trastuzumab-strf/Hercessi trastuzumab/Herceptin
May 2024 [132] aflibercept-yszy/Opuviz aflibercept/Eylea
May 2024 [132] aflibercept-jbvf/Yesafili aflibercept/Eylea
May 2024 [132] eculizumab-aeeb/Bkemv eculizumab/Soliris
June 2024 [132] ustekinumab-ttwe/Pyzchiva ustekinumab/Stelara
June 2024 [132] filgrastim-txid/Nypozi filgrastim/Neupogen
June 2024 [132] aflibercept-mrbb/Ahzantive aflibercept/Eylea
July 2024 [132] eculizumab-aagh/Epysqli eculizumab/Soliris
August 2024 [132] aflibercept-abzv/Enzeevu aflibercept/Eylea
August 2024 [132] aflibercept-ayyh/Pavblu aflibercept/Eylea
September 2024 [132] ustekinumab-aauz/Otulfi ustekinumab/Stelara

Related Research Articles

<span class="mw-page-title-main">Infliximab</span> Biopharmaceutical drug for autoimmune disorders

Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease. It is given by slow injection into a vein, typically at six- to eight-week intervals.

<span class="mw-page-title-main">Filgrastim</span> Medication

Filgrastim, sold under the brand name Neupogen among others, is a medication used to treat low neutrophil count. Low neutrophil counts may occur with HIV/AIDS, following chemotherapy or radiation poisoning, or be of an unknown cause. It may also be used to increase white blood cells for gathering during leukapheresis. It is given either by injection into a vein or under the skin. Filgrastim is a leukocyte growth factor.

<span class="mw-page-title-main">Trastuzumab</span> Medication

Trastuzumab, sold under the brand name Herceptin among others, is a monoclonal antibody used to treat breast cancer and stomach cancer. It is specifically used for cancer that is HER2 receptor positive. It may be used by itself or together with other chemotherapy medication. Trastuzumab is given by slow injection into a vein and injection just under the skin.

Etanercept, sold under the brand name Enbrel among others, is a biologic medical product that is used to treat autoimmune diseases by interfering with tumor necrosis factor (TNF), a soluble inflammatory cytokine, by acting as a TNF inhibitor. It has US Food and Drug Administration (FDA) approval to treat rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Tumor necrosis factor alpha (TNFα) is the "master regulator" of the inflammatory (immune) response in many organ systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF-alpha.

<span class="mw-page-title-main">Teriparatide</span> Pharmaceutical drug for treating osteoporosis

Teriparatide, sold under the brand name Forteo, is a form of parathyroid hormone (PTH) consisting of the first (N-terminus) 34 amino acids, which is the bioactive portion of the hormone. It is an effective anabolic agent used in the treatment of some forms of osteoporosis. Teriparatide is a recombinant human parathyroid hormone analog. It has an identical sequence to the 34 N-terminal amino acids of the 84-amino acid human parathyroid hormone.

Bevacizumab, sold under the brand name Avastin among others, is a monoclonal antibody medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, ovarian cancer, glioblastoma, hepatocellular carcinoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).

<span class="mw-page-title-main">Insulin glargine</span> Long-acting insulin

Insulin glargine sold under the brand name Lantus among others is a long-acting modified form of medical insulin, used in the management of type I and type II diabetes. It is injected just under the skin. Effects generally begin an hour after use.

Adalimumab, sold under the brand name Humira and others, is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. It is administered by subcutaneous injection. It works by inactivating tumor necrosis factor-alpha (TNFα).

Pegfilgrastim, sold under the brand name Neulasta among others, is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. It serves to stimulate the production of white blood cells (neutrophils). Pegfilgrastim was developed by Amgen.

Ranibizumab, sold under the brand name Lucentis among others, is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that is approved to treat the "wet" type of age-related macular degeneration, diabetic retinopathy, and macular edema due to branch retinal vein occlusion or central retinal vein occlusion.

<span class="mw-page-title-main">Tolvaptan</span> Chemical compound

Tolvaptan, sold under the brand name Samsca among others, is an aquaretic drug that functions as a selective, competitive vasopressin receptor 2 (V2) antagonist used to treat hyponatremia (low blood sodium levels) associated with congestive heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone (SIADH). Tolvaptan was approved by the U.S. Food and Drug Administration (FDA) on May 19, 2009, and is sold by Otsuka Pharmaceutical Co. under the trade name Samsca. Tolvaptan, as Jynarque, was granted approval for medical use in the United States in April 2018.

Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication developed by Janssen Pharmaceuticals, for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, targeting both IL-12 and IL-23.

<span class="mw-page-title-main">Denosumab</span> Human monoclonal antibody

Denosumab, sold under the brand names Prolia and Xgeva among others, is a human monoclonal antibody used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone.

Tocilizumab, sold under the brand name Actemra among others, is an immunosuppressive drug, used for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, cytokine release syndrome, COVID‑19, and systemic sclerosis-associated interstitial lung disease (SSc-ILD). It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer. Tocilizumab was jointly developed by Osaka University and Chugai, and was licensed in 2003 by Hoffmann-La Roche.

<span class="mw-page-title-main">Ofatumumab</span> Medication

Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion. Under the brand name Kesimpta, it is approved for the treatment of multiple sclerosis in the United States as well as in the European Union and other regions. Under the brand name Arzerra, it is approved for the treatment of certain types of chronic lymphocytic leukemia (CLL) in the United States. It is sold by Novartis under license from Genmab.

<span class="mw-page-title-main">Insulin lispro</span> Rapid-acting insuline analog

Insulin lispro, sold under the brand name Humalog among others, is a modified type of medical insulin used to treat type 1 and type 2 diabetes. It is delivered subcutaneously either by injection or from an insulin pump. Onset of effects typically occurs within 30 minutes and lasts about 5 hours. Often a longer-acting insulin like insulin NPH is also needed.

Aflibercept, sold under the brand names Eylea and Zaltrap among others, is a medication used to treat wet macular degeneration and metastatic colorectal cancer. It was developed by Regeneron Pharmaceuticals.

<span class="mw-page-title-main">Pasireotide</span> Pharmaceutical drug

Pasireotide, sold under the brand name Signifor, is an orphan drug approved in the United States and the European Union for the treatment of Cushing's disease in patients who fail or are ineligible for surgical therapy. It was developed by Novartis. Pasireotide is a somatostatin analog with a 40-fold increased affinity to somatostatin receptor 5 compared to other somatostatin analogs.

<span class="mw-page-title-main">Tenofovir alafenamide</span> Chemical compound

Tenofovir alafenamide, sold under the brand name Vemlidy, is an antiviral medication used against hepatitis B and HIV. It is used for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease and is given in combination with other medications for the prevention and treatment of HIV. It is taken by mouth.

<span class="mw-page-title-main">Tirbanibulin</span> Medication

Tirbanibulin, sold under the brand name Klisyri, is a medication used for the treatment of actinic keratosis (AK) on the face or scalp. It functions by inhibiting both tubulin polymerization and Src kinase signaling. It is potentially effective in impeding the development of squamous cell carcinoma in situ.

References

  1. ↑ Blanchard, A., Helene D'Iorio and Robert Ford. "What you need to know to succeed: Key trends in Canada's biotech industry " Insights, Spring 2010
  2. 1 2 Nick, C (2012). "The US Biosimilars Act: Challenges Facing Regulatory Approval". Pharm Med. 26 (3): 145–152. doi:10.1007/bf03262388. S2CID   14604362.
  3. ↑ "Biosimilars in the EU: Information guide for healthcare professionals" (PDF). European Medicines Agency and the European Commission. 2017. Archived from the original (PDF) on October 15, 2019.
  4. ↑ Lamanna WC, Holzmann J, Cohen HP, Guo X, Schweigler M, Stangler T, et al. (April 2018). "Maintaining consistent quality and clinical performance of biopharmaceuticals". Expert Opinion on Biological Therapy. 18 (4): 369–379. doi: 10.1080/14712598.2018.1421169 . PMID   29285958.
  5. ↑ Guidelines on evaluation of similar Biotherapeutic Products (SBPs) (PDF) (Report). World Health Organization (WHO). 2009. Archived from the original (PDF) on September 29, 2021. Retrieved October 24, 2019.
  6. ↑ Guidelines on evaluation of similar Biotherapeutic Products (SBPs), Annex 2, Technical Report Series No. 977 (PDF) (Report). World Health Organization (WHO). 2013. Archived (PDF) from the original on May 30, 2015. Retrieved December 18, 2019.
  7. ↑ WHO Questions and Answers: Similar Biotherapeutic Products (PDF) (Report). World Health Organization (WHO). 2018. Archived (PDF) from the original on April 21, 2019. Retrieved December 18, 2019.
  8. ↑ Guidelines on evaluation of monoclonal antibodies (mAbs) as similar biotherapeutic products (SBPs), Annex 2, Technical Report Series No. 1004 (PDF) (Report). World Health Organization (WHO). 2017. Archived (PDF) from the original on April 14, 2021. Retrieved December 18, 2019.
  9. ↑ "Biosimilar medicines: Overview". European Medicines Agency (EMA). September 17, 2018. Archived from the original on March 29, 2020. Retrieved April 21, 2020.
  10. ↑ "US Senate Committee on the Judiciary, Testimony of Dr. Lester Crawford, Acting Commissioner, FDA June 23, 2004". Archived from the original on December 28, 2016. Retrieved October 8, 2007.
  11. ↑ Hearing: Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States. Subcommittee on Health Wednesday, May 2, 2007 Archived September 22, 2007, at the Wayback Machine
  12. ↑ "FDA page on "Follow-On Protein Products: Regulatory and Scientific Issues Related to Developing"". U.S. Food and Drug Administration (FDA). Archived from the original on July 9, 2009.
  13. ↑ "FDA page on "Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting"". U.S. Food and Drug Administration (FDA). Archived from the original on October 7, 2010.
  14. ↑ "FDA Response to three Citizen Petitions against biosimilars" (PDF). U.S. Food and Drug Administration (FDA). Archived (PDF) from the original on May 31, 2017. Retrieved December 16, 2019.
  15. ↑ "FDA page on "FDA approves first biosimilar product Zarxio"". U.S. Food and Drug Administration (FDA). Archived from the original on March 7, 2015.
  16. 1 2 "Statement on low-cost biosimilar and interchangeable protein products". U.S. Food and Drug Administration (FDA). December 17, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  17. ↑ EMEA guideline on similar biological medicinal products Archived June 30, 2007, at the Wayback Machine
  18. ↑ Warren JB (January 2013). "Generics, chemisimilars and biosimilars: is clinical testing fit for purpose?". British Journal of Clinical Pharmacology. 75 (1): 7–14. doi:10.1111/j.1365-2125.2012.04323.x. PMC   3555041 . PMID   22574725.
  19. ↑ Wang X (June 1, 2014). "Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies". BioProcess International. 12 (6): 32–37. Archived from the original on January 19, 2021. Retrieved August 13, 2014.
  20. ↑ Declerck PJ (February 2013). "Biosimilar monoclonal antibodies: a science-based regulatory challenge". Expert Opinion on Biological Therapy. 13 (2): 153–6. doi: 10.1517/14712598.2012.758710 . PMID   23286777.
  21. ↑ "Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability". U.S. Food and Drug Administration (FDA). Archived from the original on September 6, 2019. Retrieved August 2, 2018.
  22. 1 2 Velásquez G (August 2018). "The International Debate on Generic Medicines of Biological Origin" (PDF). South Centre Policy Brief (50). Archived (PDF) from the original on March 6, 2021. Retrieved December 23, 2020.
  23. ↑ "Australian Government Announces Decision on Biosimilar Naming Conventions". The Center For Biosimilars. January 31, 2018. Archived from the original on December 30, 2021. Retrieved December 20, 2021.
  24. ↑ "Biosimilar medicines regulation". Therapeutic Goods Administration (TGA). April 4, 2018. Archived from the original on December 30, 2021. Retrieved December 29, 2021.
  25. ↑ "Which biosimilar medicines are available in Australia?". Archived from the original on December 30, 2021. Retrieved December 29, 2021.
  26. ↑ "Biological Qualifier". WHO. Archived from the original on March 28, 2015.
  27. ↑ "WHO Report on the Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products" (PDF). Archived (PDF) from the original on October 31, 2017. Retrieved August 2, 2019.
  28. ↑ "Which biosimilar medicines are available in Australia?". Archived from the original on December 30, 2021. Retrieved December 30, 2021.
  29. ↑ Fasseeh AN, Elezbawy B, El-Fass KA, GamaI M, Seyam A, Hayek N, et al. (June 2023). "Maximizing the benefits of using biosimilars in Egypt". Journal of Pharmaceutical Policy and Practice. 16 (1): 79. doi: 10.1186/s40545-023-00581-w . PMC   10291771 . PMID   37365620.
  30. ↑ "Biosimilar medicines can be interchanged". European Medicines Agency (EMA) (Press release). September 19, 2022. Archived from the original on September 20, 2022. Retrieved September 19, 2022.
  31. ↑ "EU Approved biosimilars by molecule [data arranged from EMA website]" (PDF). Biosimilars Nederland. Archived (PDF) from the original on September 19, 2020. Retrieved June 9, 2020.
  32. ↑ "Humira EPAR". European Medicines Agency (EMA). Archived from the original on February 18, 2020. Retrieved March 7, 2024.
  33. ↑ "Amgevita EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 21, 2020.
  34. ↑ "Amsparity EPAR". European Medicines Agency (EMA). December 9, 2019. Archived from the original on February 18, 2020. Retrieved April 21, 2020.
  35. ↑ "Cyltezo EPAR". European Medicines Agency (EMA). Archived from the original on August 6, 2020. Retrieved August 27, 2021.
  36. ↑ "Halimatoz EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 21, 2020.
  37. ↑ "Hefiya EPAR". European Medicines Agency (EMA). Archived from the original on October 15, 2019. Retrieved April 21, 2020.
  38. ↑ "Hukyndra EPAR". European Medicines Agency (EMA). September 14, 2021. Archived from the original on April 24, 2022. Retrieved April 23, 2022.
  39. ↑ "Hulio EPAR". European Medicines Agency (EMA). Archived from the original on March 24, 2020. Retrieved April 21, 2020.
  40. ↑ "Hyrimoz EPAR". European Medicines Agency (EMA). Archived from the original on November 16, 2019. Retrieved April 21, 2020.
  41. ↑ "Idacio EPAR". European Medicines Agency (EMA). January 29, 2019. Archived from the original on December 30, 2019. Retrieved April 21, 2020.
  42. ↑ "Imraldi EPAR". European Medicines Agency (EMA). Archived from the original on March 24, 2020. Retrieved April 21, 2020.
  43. ↑ "Kromeya EPAR". European Medicines Agency (EMA). January 29, 2019. Archived from the original on December 30, 2019. Retrieved August 27, 2021.
  44. ↑ "Libmyris EPAR". European Medicines Agency (EMA). September 14, 2021. Archived from the original on April 24, 2022. Retrieved April 23, 2022.
  45. ↑ "Solymbic EPAR". European Medicines Agency (EMA). Archived from the original on June 25, 2019. Retrieved August 27, 2021.
  46. ↑ "Trudexa EPAR". European Medicines Agency (EMA). Archived from the original on February 18, 2020. Retrieved August 27, 2021.
  47. ↑ "Yuflyma EPAR". European Medicines Agency (EMA). December 9, 2020. Archived from the original on August 28, 2021. Retrieved August 27, 2021.
  48. ↑ "Avastin EPAR". European Medicines Agency (EMA). Archived from the original on March 18, 2020. Retrieved September 11, 2021.
  49. ↑ "Abevmy EPAR". European Medicines Agency (EMA). February 24, 2021. Archived from the original on August 28, 2021. Retrieved August 27, 2021.
  50. ↑ "Alymsys EPAR". European Medicines Agency (EMA). January 25, 2021. Archived from the original on October 8, 2021. Retrieved September 11, 2021.
  51. ↑ "Aybintio EPAR". European Medicines Agency (EMA). May 26, 2020. Archived from the original on December 29, 2020. Retrieved September 9, 2020.
  52. ↑ "Equidacent EPAR". European Medicines Agency (EMA). July 20, 2020. Archived from the original on October 13, 2020. Retrieved October 12, 2020.
  53. ↑ "Mvasi EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 2, 2020.
  54. ↑ "Onbevzi EPAR". European Medicines Agency (EMA). November 9, 2020. Archived from the original on November 5, 2021. Retrieved September 11, 2021.
  55. ↑ "Oyavas EPAR". European Medicines Agency (EMA). January 25, 2021. Archived from the original on October 8, 2021. Retrieved September 11, 2021.
  56. ↑ "Vegzelma EPAR". European Medicines Agency (EMA). June 20, 2022. Archived from the original on January 28, 2023. Retrieved March 3, 2023.
  57. ↑ "Zirabev EPAR". European Medicines Agency (EMA). December 11, 2018. Archived from the original on December 30, 2019. Retrieved April 2, 2020.
  58. 1 2 "Inhixa EPAR". European Medicines Agency (EMA). Archived from the original on October 29, 2020. Retrieved September 9, 2020.
  59. ↑ "Thorinane EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 2, 2020.
  60. ↑ "Abseamed EPAR". European Medicines Agency (EMA). Archived from the original on March 23, 2020. Retrieved April 4, 2022.
  61. ↑ "Binocrit EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  62. ↑ "Epoetin Alfa Hexal EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  63. ↑ "Retacrit EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  64. ↑ "Silapo EPAR". European Medicines Agency (EMA). Archived from the original on October 22, 2020. Retrieved April 4, 2022.
  65. ↑ "Enbrel EPAR". European Medicines Agency (EMA). Archived from the original on November 12, 2020. Retrieved March 7, 2024.
  66. ↑ "Benepali EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  67. ↑ "Erelzi EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  68. ↑ "Lifmior EPAR". European Medicines Agency (EMA). Retrieved April 2, 2020.
  69. ↑ "Nepexto EPAR". European Medicines Agency (EMA). March 24, 2020. Archived from the original on June 4, 2020. Retrieved June 4, 2020.
  70. 1 2 "Nivestim EPAR". European Medicines Agency (EMA). Archived from the original on December 20, 2019. Retrieved April 4, 2022.
  71. ↑ "Accofil EPAR". European Medicines Agency (EMA). Archived from the original on March 23, 2020. Retrieved April 4, 2022.
  72. ↑ "Biograstim EPAR". European Medicines Agency (EMA). September 17, 2018. Archived from the original on October 22, 2020. Retrieved April 2, 2020.
  73. ↑ "Filgrastim Hexal EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  74. ↑ "Filgrastim ratiopharm EPAR". European Medicines Agency (EMA). September 17, 2018. Archived from the original on January 21, 2021. Retrieved April 2, 2020.
  75. ↑ "Grastofil EPAR". European Medicines Agency (EMA). Archived from the original on November 12, 2020. Retrieved April 4, 2022.
  76. ↑ "Ratiograstim EPAR". European Medicines Agency (EMA). Archived from the original on August 14, 2020. Retrieved April 4, 2022.
  77. ↑ "Tevagrastim EPAR". European Medicines Agency (EMA). Archived from the original on October 16, 2019. Retrieved April 4, 2022.
  78. ↑ "Zarzio EPAR". European Medicines Agency (EMA). Archived from the original on October 15, 2019. Retrieved April 4, 2022.
  79. ↑ "Gonal-f EPAR". European Medicines Agency (EMA). October 20, 1995. Archived from the original on July 1, 2020. Retrieved March 7, 2024.
  80. ↑ "Bemfola EPAR". European Medicines Agency (EMA). Archived from the original on October 28, 2020. Retrieved September 9, 2020.
  81. ↑ "Ovaleap EPAR". European Medicines Agency (EMA). Archived from the original on September 23, 2020. Retrieved September 9, 2020.
  82. ↑ "Remicade EPAR". European Medicines Agency (EMA). Archived from the original on October 22, 2020. Retrieved March 7, 2024.
  83. ↑ "Flixabi EPAR". European Medicines Agency (EMA). Archived from the original on October 16, 2019. Retrieved April 4, 2022.
  84. ↑ "Inflectra EPAR". European Medicines Agency (EMA). Archived from the original on October 16, 2019. Retrieved April 4, 2022.
  85. ↑ "Remsima EPAR". European Medicines Agency (EMA). Archived from the original on December 29, 2019. Retrieved April 4, 2022.
  86. ↑ "Zessly EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 4, 2022.
  87. ↑ "NovoRapid EPAR". European Medicines Agency (EMA). Archived from the original on September 22, 2023. Retrieved March 7, 2024.
  88. ↑ "Fiasp EPAR". European Medicines Agency (EMA). Archived from the original on August 28, 2021. Retrieved August 27, 2021.
  89. ↑ "Insulin aspart Sanofi EPAR". European Medicines Agency (EMA). April 28, 2020. Archived from the original on July 17, 2020. Retrieved September 9, 2020.
  90. ↑ "Kirsty EPAR". European Medicines Agency (EMA). December 9, 2020. Archived from the original on September 15, 2021. Retrieved September 14, 2021.
  91. ↑ "NovoMix EPAR". European Medicines Agency (EMA). Archived from the original on April 13, 2020. Retrieved August 27, 2021.
  92. ↑ "Ryzodeg EPAR". European Medicines Agency (EMA). Archived from the original on August 28, 2021. Retrieved August 27, 2021.
  93. ↑ "Lantus EPAR". European Medicines Agency (EMA). Archived from the original on August 4, 2020. Retrieved March 7, 2024.
  94. ↑ "Abasaglar EPAR". European Medicines Agency (EMA). Archived from the original on April 2, 2022. Retrieved April 4, 2022.
  95. ↑ "Semglee EPAR". European Medicines Agency (EMA). Archived from the original on February 15, 2022. Retrieved April 4, 2022.
  96. ↑ "Humalog EPAR". European Medicines Agency (EMA). Archived from the original on February 24, 2020. Retrieved March 7, 2024.
  97. ↑ "Insulin lispro Sanofi EPAR". European Medicines Agency (EMA). Archived from the original on February 24, 2020. Retrieved September 9, 2020.
  98. ↑ "Neulasta EPAR". European Medicines Agency (EMA). Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  99. ↑ "Cegfila (previously Pegfilgrastim Mundipharma) EPAR". European Medicines Agency (EMA). October 16, 2019. Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  100. ↑ "Fulphila EPAR". European Medicines Agency (EMA). September 24, 2018. Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  101. ↑ "Grasustek EPAR". European Medicines Agency (EMA). April 24, 2019. Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  102. ↑ "Pelgraz EPAR". European Medicines Agency (EMA). Archived from the original on December 30, 2019. Retrieved April 2, 2020.
  103. ↑ "Pelmeg EPAR". European Medicines Agency (EMA). September 24, 2018. Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  104. ↑ "Udenyca". European Medicines Agency (EMA. Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  105. ↑ "Stimufend EPAR". European Medicines Agency (EMA). January 24, 2022. Archived from the original on April 21, 2022. Retrieved April 4, 2022.
  106. ↑ "Ziextenzo EPAR". European Medicines Agency (EMA). September 24, 2018. Archived from the original on June 11, 2020. Retrieved April 2, 2020.
  107. ↑ "Lucentis EPAR". European Medicines Agency (EMA). Archived from the original on September 10, 2021. Retrieved September 9, 2021.
  108. ↑ "Byooviz EPAR". European Medicines Agency (EMA). June 23, 2021. Archived from the original on September 10, 2021. Retrieved September 9, 2021.
  109. ↑ "Ranivisio EPAR". European Medicines Agency (EMA). June 20, 2022. Archived from the original on October 6, 2022. Retrieved October 6, 2022.
  110. ↑ "Ximluci EPAR". European Medicines Agency (EMA). September 14, 2022. Archived from the original on March 13, 2023. Retrieved March 3, 2023.
  111. ↑ "MabThera EPAR". European Medicines Agency (EMA). Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  112. ↑ "Blitzima EPAR". European Medicines Agency (EMA). Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  113. ↑ "Ritemvia EPAR". European Medicines Agency (EMA). Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  114. ↑ "Rituzena EPAR". European Medicines Agency (EMA). Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  115. ↑ "Rixathon EPAR". European Medicines Agency (EMA). Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  116. ↑ "Riximyo EPAR". European Medicines Agency (EMA). Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  117. ↑ "Ruxience EPAR". European Medicines Agency (EMA). January 29, 2020. Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  118. ↑ "Truxima EPAR". European Medicines Agency (EMA). Archived from the original on September 9, 2021. Retrieved September 8, 2021.
  119. 1 2 "Omnitrope EPAR". European Medicines Agency (EMA). Archived from the original on July 27, 2020. Retrieved April 2, 2020.
  120. ↑ "Forsteo EPAR". European Medicines Agency (EMA). Archived from the original on June 27, 2020. Retrieved March 7, 2024.
  121. ↑ "Movymia EPAR". European Medicines Agency (EMA). Archived from the original on May 1, 2022. Retrieved April 4, 2022.
  122. ↑ "Terrosa EPAR". European Medicines Agency (EMA). Archived from the original on August 14, 2019. Retrieved April 4, 2022.
  123. ↑ "RoActemra EPAR". European Medicines Agency. January 16, 2009. Archived from the original on December 18, 2021. Retrieved March 7, 2024.
  124. ↑ "Tyenne EPAR". European Medicines Agency (EMA). Archived from the original on October 5, 2023. Retrieved March 7, 2024.
  125. ↑ "Herceptin EPAR". European Medicines Agency (EMA). Archived from the original on July 28, 2020. Retrieved July 28, 2020.
  126. ↑ "Herzuma EPAR". European Medicines Agency (EMA). Archived from the original on November 8, 2020. Retrieved July 28, 2020.
  127. ↑ "Kanjinti EPAR". European Medicines Agency (EMA). Archived from the original on October 31, 2020. Retrieved July 28, 2020.
  128. ↑ "Ogivri EPAR". European Medicines Agency (EMA). Archived from the original on March 24, 2020. Retrieved July 28, 2020.
  129. ↑ "Ontruzant EPAR". European Medicines Agency (EMA). Archived from the original on August 4, 2020. Retrieved July 28, 2020.
  130. ↑ "Trazimera EPAR". European Medicines Agency (EMA). Archived from the original on July 28, 2020. Retrieved July 28, 2020.
  131. ↑ "Zercepac EPAR". European Medicines Agency (EMA). May 26, 2020. Archived from the original on July 28, 2020. Retrieved July 28, 2020.
  132. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 "Biosimilar Drug Information". U.S. Food and Drug Administration (FDA). Archived from the original on October 8, 2024. Retrieved October 8, 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  133. ↑ "FDA Roundup: October 4, 2024". U.S. Food and Drug Administration (FDA) (Press release). October 4, 2024. Retrieved October 8, 2024.
  134. ↑ "Biosimilars". U.S. Food and Drug Administration. July 27, 2021. Archived from the original on August 28, 2021. Retrieved August 28, 2021.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  135. ↑ Epstein MS, Ehrenpreis ED, Kulkarni PM (December 2014). "Biosimilars: the need, the challenge, the future: the FDA perspective" (PDF). The American Journal of Gastroenterology. 109 (12): 1856–9. doi:10.1038/ajg.2014.151. PMID   24957160. S2CID   19274464. Archived from the original (PDF) on October 6, 2016. Retrieved September 25, 2016.
  136. ↑ "Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency's biosimilars policy framework". U.S. Food and Drug Administration (FDA) (Press release). December 11, 2018. Archived from the original on May 8, 2019. Retrieved December 16, 2018.
  137. ↑ "Zarxio (filgrastim-sndz)". U.S. Food and Drug Administration (FDA). April 20, 2015. Archived from the original on December 20, 2019. Retrieved December 17, 2019.
  138. ↑ "Inflectra (infliximab-dyyb) for Injection". U.S. Food and Drug Administration (FDA). June 27, 2016. Archived from the original on May 20, 2022. Retrieved November 26, 2023.
  139. ↑ "FDA approves Erelzi, a biosimilar to Enbrel" (Press release). U.S. Food and Drug Administration (FDA). Archived from the original on August 28, 2021. Retrieved December 17, 2020.
  140. ↑ "Drug Approval Package: Erelzi (etanercept-szzs)". U.S. Food and Drug Administration (FDA). October 25, 2016. Archived from the original on December 5, 2022. Retrieved November 26, 2023.
  141. ↑ "FDA approves Amjevita, a biosimilar to Humira" (Press release). U.S. Food and Drug Administration (FDA). Archived from the original on November 19, 2019. Retrieved December 17, 2020.
  142. ↑ "Drug Approval Package: Amjevita (adalimumab-atto)". U.S. Food and Drug Administration (FDA). November 9, 2016. Archived from the original on October 4, 2020. Retrieved November 26, 2023.
  143. ↑ "Drug Approval Package: Renflexis (infliximab-abda)". U.S. Food and Drug Administration (FDA). December 10, 2018. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  144. ↑ "Cyltezo: FDA Approved Drug Products". U.S. Food and Drug Administration (FDA). Archived from the original on February 18, 2020. Retrieved August 28, 2017.
  145. ↑ "FDA approves first biosimilar for the treatment of cancer" (Press release). U.S. Food and Drug Administration (FDA). Archived from the original on November 5, 2021. Retrieved December 17, 2020.
  146. ↑ "Drug Approval Package: Mvasi (bevacizumab-awwb)". U.S. Food and Drug Administration (FDA). October 10, 2018. Archived from the original on February 23, 2023. Retrieved November 26, 2023.
  147. ↑ "FDA approves first biosimilar for the treatment of certain breast and stomach cancers" (Press release). U.S. Food and Drug Administration (FDA). Archived from the original on December 15, 2019. Retrieved December 17, 2020.
  148. ↑ "Drug Approval Package: Ogivri (Trastuzumab-dkst)". U.S. Food and Drug Administration (FDA). November 29, 2018. Archived from the original on March 22, 2023. Retrieved November 26, 2023.
  149. ↑ "Drug Approval Package: Ixifi (infliximab-qbtx)". U.S. Food and Drug Administration (FDA). November 29, 2018. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  150. ↑ "FDA approves first epoetin alfa biosimilar for the treatment of anemia" (Press release). U.S. Food and Drug Administration (FDA). Archived from the original on August 28, 2021. Retrieved December 17, 2020.
  151. ↑ "Drug Approval Package: Retacrit (epoetin alfa-epbx )". U.S. Food and Drug Administration (FDA). December 13, 2018. Archived from the original on September 27, 2021. Retrieved November 26, 2023.
  152. ↑ "FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment" (Press release). U.S. Food and Drug Administration (FDA). Archived from the original on June 11, 2020. Retrieved December 17, 2020.
  153. ↑ "Drug Approval Package: Fulphila". U.S. Food and Drug Administration (FDA). October 26, 2018. Archived from the original on June 11, 2020. Retrieved November 26, 2023.
  154. ↑ "Drug Approval Package: Nivestym (filgrastim-aafi)". U.S. Food and Drug Administration (FDA). February 21, 2019. Archived from the original on December 20, 2019. Retrieved December 17, 2019.
  155. ↑ "Drug Approval Package: Hyrimoz". U.S. Food and Drug Administration (FDA). March 21, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  156. ↑ "Drug Approval Package: Udenyca". U.S. Food and Drug Administration (FDA). March 5, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  157. ↑ "Drug Approval Package: Truxima (rituximab-abbs)". U.S. Food and Drug Administration (FDA). February 25, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  158. ↑ "Drug Approval Package: Herzuma". U.S. Food and Drug Administration (FDA). February 7, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  159. ↑ "Drug Approval Package: Ontruzant (trastuzumab-dttb)". U.S. Food and Drug Administration (FDA). March 5, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  160. ↑ "Drug Approval Package: Trazimera (trastuzumab-qyyp)". U.S. Food and Drug Administration (FDA). May 17, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  161. ↑ "Drug Approval Package: Eticovo". U.S. Food and Drug Administration (FDA). June 18, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  162. ↑ "Drug Approval Package: Kanjinti". U.S. Food and Drug Administration (FDA). July 18, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  163. ↑ "Drug Approval Package: Zirabev". U.S. Food and Drug Administration (FDA). August 14, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  164. ↑ "Drug Approval Package: Ruxience". U.S. Food and Drug Administration (FDA). August 9, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  165. ↑ "Drug Approval Package: Hadlima". U.S. Food and Drug Administration (FDA). September 5, 2019. Archived from the original on December 18, 2019. Retrieved December 17, 2019.
  166. ↑ "Drug Approval Package: Ziextenzo". U.S. Food and Drug Administration (FDA). December 27, 2019. Archived from the original on June 11, 2020. Retrieved December 17, 2020.
  167. ↑ "Drug Approval Package: Abrilada". U.S. Food and Drug Administration (FDA). January 28, 2020. Archived from the original on October 4, 2020. Retrieved December 17, 2020.
  168. ↑ "Drug Approval Package: Avsola". U.S. Food and Drug Administration (FDA). January 30, 2020. Archived from the original on November 1, 2020. Retrieved December 17, 2020.
  169. ↑ "Drug Approval Package: Nyvepria". U.S. Food and Drug Administration (FDA). August 11, 2020. Archived from the original on January 25, 2021. Retrieved December 17, 2020.
  170. ↑ "Drug Approval Package: Hulio". U.S. Food and Drug Administration (FDA). October 2, 2020. Archived from the original on November 6, 2021. Retrieved December 17, 2020.
  171. ↑ "Drug Approval Package: Riabni". U.S. Food and Drug Administration (FDA). January 26, 2021. Archived from the original on August 28, 2021. Retrieved August 28, 2021.
  172. ↑ "Drug Approval Package: Semglee". U.S. Food and Drug Administration (FDA). September 2, 2021. Archived from the original on May 27, 2022. Retrieved May 26, 2022.
  173. ↑ "Drug Approval Package: Byooviz". U.S. Food and Drug Administration (FDA). October 1, 2021. Archived from the original on January 25, 2023. Retrieved August 25, 2023.
  174. ↑ "Drug Approval Package: Rezvoglar". U.S. Food and Drug Administration (FDA). January 28, 2022. Archived from the original on May 27, 2022. Retrieved May 26, 2022.
  175. ↑ "Drug Approval Package: Yusimry". U.S. Food and Drug Administration (FDA). January 18, 2021. Archived from the original on May 27, 2022. Retrieved May 26, 2022.
  176. ↑ "Drug Approval Package: Releuko". U.S. Food and Drug Administration (FDA). April 11, 2022. Archived from the original on May 27, 2022. Retrieved May 26, 2022.
  177. ↑ "Drug Approval Package: Alymsys". U.S. Food and Drug Administration (FDA). May 11, 2022. Archived from the original on May 27, 2022. Retrieved May 27, 2022.
  178. ↑ "Drug Approval Package: Fylnetra". U.S. Food and Drug Administration (FDA). July 15, 2022. Archived from the original on September 3, 2022. Retrieved August 25, 2023.
  179. ↑ "Drug Approval Package: Cimerli". U.S. Food and Drug Administration (FDA). August 23, 2022. Archived from the original on September 29, 2022. Retrieved September 28, 2022.
  180. ↑ "Drug Approval Package: Stimufend". U.S. Food and Drug Administration (FDA). November 16, 2022. Archived from the original on January 26, 2023. Retrieved August 25, 2023.
  181. ↑ "Drug Approval Package: Vegzelma". U.S. Food and Drug Administration (FDA). December 13, 2022. Archived from the original on August 25, 2023. Retrieved August 25, 2023.
  182. ↑ "Drug Approval Package: Idacio". U.S. Food and Drug Administration (FDA). February 9, 2023. Archived from the original on February 10, 2023. Retrieved August 25, 2023.
  183. ↑ "Drug Approval Package: Yuflyma injection". U.S. Food and Drug Administration (FDA). August 11, 2023. Archived from the original on August 25, 2023. Retrieved August 25, 2023.
  184. ↑ "Drug Approval Package: Tyruko". U.S. Food and Drug Administration (FDA). October 11, 2023. Archived from the original on November 26, 2023. Retrieved November 26, 2023.
  185. ↑ "Drug Approval Package: Tofidence". U.S. Food and Drug Administration (FDA). November 7, 2023. Retrieved November 26, 2023.
  186. ↑ "FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases" (Press release). U.S. Food and Drug Administration (FDA). October 31, 2023. Archived from the original on November 13, 2023. Retrieved November 13, 2023.

Further reading

This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.