Ranibizumab

Last updated

Ranibizumab
Monoclonal antibody
Type Fab fragment
Source Humanized (from mouse)
Target Vascular endothelial growth factor A (VEGF-A)
Clinical data
Trade names Lucentis, others
Biosimilars Byooviz, [1] [2] Cimerli, [3] Ranivisio, [4] Raniviz, [5] Ranopto, Susvimo, [6] Ximluci [7] ranibizumab-eqrn, [3] ranibizumab-nuna [1]
AHFS/Drugs.com Monograph
MedlinePlus a607044
License data
Pregnancy
category
Routes of
administration
Intravitreal injection
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life Approx. 9 days [13]
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
Formula C2158H3282N562O681S12
Molar mass 48379.97 g·mol−1
 X mark.svgNYes check.svgY  (what is this?)    (verify)

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 [15] that is approved to treat the "wet" type of age-related macular degeneration (AMD, also ARMD), diabetic retinopathy, and macular edema due to branch retinal vein occlusion or central retinal vein occlusion.

Contents

Ranibizumab was developed by Genentech and marketed by them in the United States, and elsewhere by Novartis, [16] under the brand name Lucentis. [13] [16] [17] Ranibizumab (Lucentis) was approved for medical use in the United States in June 2006, [17] [13] and in the European Union in January 2007.

Medical uses

In the United States, ranibizumab is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. [13] [18]

In the European Union, ranibizumab is indicated for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion, and visual impairment due to choroidal neovascularisation. [14] [2] [4]

It is used for age-related wet macular degeneration. [19] Its effectiveness is similar to that of bevacizumab [20] [21] and aflibercept. [22] A 2023 systematic review update found that while ranibizumab and bevacizumab provide similar functional outcomes in diabetic macular edema, there is low-certainty evidence suggesting that ranibizumab is more effective in reducing central retinal thickness than bevacizumab. [23]

Susvimo is a reformulation of ranibizumab suitable for injection via ocular implant. [24] Susvimo was approved for medical use in the United States in October 2021. [6] [25]

Side effects

A 2014 Cochrane review did not find a difference between bevacizumab and ranibizumab in deaths or total severe side effects when used for macular degeneration. [26] There, however, was not a lot of evidence, and thus this conclusion is not that certain. [26]

Ranibizumab does appear to result in a lower risk of stomach and intestinal problems. [26] It is also associated with a low rate of eye related side effects. [27]

Serious adverse events related to the injection procedure occurred with an incidence rate of less than 1% and included endophthalmitis, retinal detachment, and traumatic cataracts. Other serious ocular adverse events observed among ranibizumab-treated patients (incidence rate < 1%) included intraocular inflammation and blindness. [28]

Interactions

No significant interactions are known. [29]

Pharmacology

Ranibizumab is a monoclonal antibody that inhibits angiogenesis by inhibiting vascular endothelial growth factor A, a mechanism similar to that of Bevacizumab. [30]

Society and culture

Economics

Its effectiveness is similar to that of bevacizumab. [20] [31] Its rates of side effects also appear similar. [26] However, ranibizumab typically costs $2,000 a dose, while the equivalent dose of bevacizumab typically costs $50. [32] [33] [34] [35]

Genentech offered secret rebates to about 300 ophthalmologists in an apparent inducement to get them to use more ranibizumab rather than the less expensive bevacizumab. In 2008, bevacizumab cost Medicare only $20 million for about 480,000 injections, while ranibizumab cost Medicare $537 million for only 337,000 injections. [36] A small study showed no superior effect of ranibizumab versus bevacizumab in direct comparison. [37] The initial results of the larger Comparison of Age-related Macular Degeneration Treatments Trials (CATT) found that the two drugs "had equivalent effects on visual acuity when administered according to the same schedule;" however, serious adverse events were more common in the bevacizumab arm of the trial. [33]

According to a 2012 meta-analysis, the results of several subsequent head-to-head trials found that the two therapies performed equally at restoring visual acuity. [38] [39] A 2012 meta-analysis focused specifically on safety issues concluded that the rates of several adverse events were higher with bevacizumab, although the absolute rates of ocular serious adverse events were low with both therapies: ocular adverse events were about 2.8 times as frequent with bevacizumab than with ranibizumab. [31]

Biosimilars

Byooviz was approved for medical use in the European Union in August 2021. [2] [40]

Ranibizumab-nuna (Byooviz) was approved for medical use in the United States in September 2021. [1] [18]

In India, Lupin Limited received marketing approval for its biosimilar of Ranibizumab. [41]

In June 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ranivisio, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular edema or choroidal neovascularization, and proliferative diabetic retinopathy. [42] The applicant for this medicinal product is Midas Pharma GmbH. [42] Ranivisio was approved for medical use in the European Union in August 2022. [4] [43]

Ranibizumab-eqrn (Cimerli) was approved for medical use in the United States in August 2022. [3] [44]

In September 2022, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ximluci, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularization. [45] The applicant for this medicinal product is STADA Arzneimittel AG. [45] Ximluci was approved for medical use in the European Union in November 2022. [7] [46]

In November 2023, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rimmyrah, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularization. [47] The applicant for this medicinal product is QILU PHARMA SPAIN S.L. [47] Rimmyrah is a biosimilar medicinal product that is highly similar to the reference product Lucentis (ranibizumab), which was authorized in the EU in January 2007. [47]

In January 2024, Sandoz signed an agreement to acquire ranibizumab-eqrn, the biosimilar version of ranibizumab branded as Cimerli from Coherus BioSciences, Inc. for an upfront cash purchase payment of US$170 million. [48] [49] [50]

Related Research Articles

<span class="mw-page-title-main">Diabetic retinopathy</span> Diabetes-induced damage to the retina of the eye

Diabetic retinopathy, is a medical condition in which damage occurs to the retina due to diabetes. It is a leading cause of blindness in developed countries.

The National Eye Institute (NEI) is part of the U.S. National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services. The mission of NEI is "to eliminate vision loss and improve quality of life through vision research." NEI consists of two major branches for research: an extramural branch that funds studies outside NIH and an intramural branch that funds research on the NIH campus in Bethesda, Maryland. Most of the NEI budget funds extramural research.

<span class="mw-page-title-main">Macular edema</span> Medical condition

Macular edema occurs when fluid and protein deposits collect on or under the macula of the eye and causes it to thicken and swell (edema). The swelling may distort a person's central vision, because the macula holds tightly packed cones that provide sharp, clear, central vision to enable a person to see detail, form, and color that is directly in the centre of the field of view.

<span class="mw-page-title-main">Macular degeneration</span> Medical condition associated with vision loss

Macular degeneration, also known as age-related macular degeneration, is a medical condition which may result in blurred or no vision in the center of the visual field. Early on there are often no symptoms. Over time, however, some people experience a gradual worsening of vision that may affect one or both eyes. While it does not result in complete blindness, loss of central vision can make it hard to recognize faces, drive, read, or perform other activities of daily life. Visual hallucinations may also occur.

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, 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">Bruch's membrane</span> Component of the eye

Bruch's membrane or lamina vitrea is the innermost layer of the choroid of the eye. It is also called the vitreous lamina or Membrane vitriae, because of its glassy microscopic appearance. It is 2–4 μm thick.

<span class="mw-page-title-main">Triamcinolone acetonide</span> Medicinal chemical compound, steroid

Triamcinolone acetonide, sold under the brand name Kenalog among others, is a synthetic corticosteroid medication used topically to treat various skin conditions, to relieve the discomfort of mouth sores, and by injection into joints to treat various joint conditions. It is also injected into lesions to treat inflammation in some parts of the body, particularly the skin. In nasal spray form, it is used to treat allergic rhinitis. It is used for the treatment of macular edema associated with uveitis. It is a more potent derivative of triamcinolone, and is about eight times as potent as prednisone.

<span class="mw-page-title-main">Intravitreal administration</span>

Intravitreal administration is a route of administration of a drug, or other substance, in which the substance is delivered into the vitreous humor of the eye. "Intravitreal" literally means "inside an eye". Intravitreal injections were first introduced in 1911 when Ohm gave an injection of air into the vitreous humor to repair a detached retina. In the mid-1940s, intravitreal injections became a standard way to administer drugs to treat endophthalmitis and cytomegalovirus retinitis.

<span class="mw-page-title-main">Pegaptanib</span> Drug to treat macular degeneration

Pegaptanib sodium injection is an anti-angiogenic medicine for the treatment of neovascular (wet) age-related macular degeneration (AMD). It was discovered by NeXstar Pharmaceuticals and licensed in 2000 to EyeTech Pharmaceuticals, now OSI Pharmaceuticals, for late stage development and marketing in the United States. Gilead Sciences continues to receive royalties from the drugs licensing. Outside the US pegaptanib is marketed by Pfizer. Approval was granted by the U.S. Food and Drug Administration (FDA) in December 2004.

<span class="mw-page-title-main">Choroidal neovascularization</span> Creation of new blood vessels in the choroid layer of the eye

Choroidal neovascularization (CNV) is the creation of new blood vessels in the choroid layer of the eye. Choroidal neovascularization is a common cause of neovascular degenerative maculopathy commonly exacerbated by extreme myopia, malignant myopic degeneration, or age-related developments.

Calvin Alexander Grant is an American ophthalmologist.

Aflibercept, sold under the brand names Eylea 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">Macular telangiectasia</span> Disease of the retina affecting central vision

Macular telangiectasia is a condition of the retina, the light-sensing tissue at the back of the eye that causes gradual deterioration of central vision, interfering with tasks such as reading and driving.

<span class="mw-page-title-main">Napoleone Ferrara</span> Italian-American molecular biologist

Napoleone Ferrara is an Italian-American molecular biologist who joined University of California, San Diego Moores Cancer Center in 2013 after a career in Northern California at the biotechnology giant Genentech, where he pioneered the development of new treatments for angiogenic diseases such as cancer, age-related macular degeneration (AMD), and diabetic retinopathy. At Genentech, he discovered VEGF—and made the first anti-VEGF antibody—which suppresses growth of a variety of tumors. These findings helped lead to development of the first clinically available angiogenesis inhibitor, bevacizumab (Avastin), which prevents the growth of new blood vessels into a solid tumor and which has become part of standard treatment for a variety of cancers. Ferrara's work led also to the development of ranibizumab (Lucentis), a drug that is highly effective at preventing vision loss in intraocular neovascular disorders.

<span class="mw-page-title-main">Laser coagulation</span> Procedure widely used in eye surgery

Laser coagulation or laser photocoagulation surgery is used to treat a number of eye diseases and has become widely used in recent decades. During the procedure, a laser is used to finely cauterize ocular blood vessels to attempt to bring about various therapeutic benefits.

Joan Whitten Miller is a Canadian-American ophthalmologist and scientist who has made notable contributions to the treatment and understanding of eye disorders. She is credited for developing photodynamic therapy (PDT) with verteporfin (Visudyne), the first pharmacologic therapy for retinal disease. She also co-discovered the role of vascular endothelial growth factor (VEGF) in eye disease and demonstrated the therapeutic potential of VEGF inhibitors, forming the scientific basis of anti-VEGF therapy for age-related macular degeneration (AMD), diabetic retinopathy, and related conditions.

Anti–vascular endothelial growth factor therapy, also known as anti-VEGF therapy or medication, is the use of medications that block vascular endothelial growth factor. This is done in the treatment of certain cancers and in age-related macular degeneration. They can involve monoclonal antibodies such as bevacizumab, antibody derivatives such as ranibizumab (Lucentis), or orally-available small molecules that inhibit the tyrosine kinases stimulated by VEGF: sunitinib, sorafenib, axitinib, and pazopanib.

<span class="mw-page-title-main">Faricimab</span> Medication for macular degeneration

Faricimab, sold under the brand name Vabysmo, is a monoclonal antibody used for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Faricimab is the first bispecific monoclonal antibody to target both vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2). By targeting these pathways, faricimab stabilizes blood vessels in the retina. It is given by intravitreal injection by an ophthalmologist.

<span class="mw-page-title-main">Intravitreal injection</span> Method of administration of drugs into the eye by injection with a fine needle

Intravitreal injection is the method of administration of drugs into the eye by injection with a fine needle. The medication will be directly applied into the vitreous humor. It is used to treat various eye diseases, such as age-related macular degeneration (AMD), diabetic retinopathy, and infections inside the eye such as endophthalmitis. As compared to topical administration, this method is beneficial for a more localized delivery of medications to the targeted site, as the needle can directly pass through the anatomical eye barrier and dynamic barrier. It could also minimize adverse drug effects on other body tissues via the systemic circulation, which could be a possible risk for intravenous injection of medications. Although there are risks of infections or other complications, with suitable precautions throughout the injection process, chances for these complications could be lowered.

Conbercept, sold under the commercial name Lumitin, is a novel vascular endothelial growth factor (VEGF) inhibitor used to treat neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME). The anti-VEGF was approved for the treatment of neovascular AMD by the China State FDA (CFDA) in December 2013. As of December 2020, conbercept is undergoing phase III clinical trials through the U.S. Food and Drug Administration’s PANDA-1 and PANDA-2 development programs.

References

  1. 1 2 3 4 "Byooviz Nuna- ranibizumab injection, solution". DailyMed. 27 April 2022. Archived from the original on 3 August 2022. Retrieved 2 August 2022.
  2. 1 2 3 4 "Byooviz EPAR". European Medicines Agency. 23 June 2021. Archived from the original on 10 September 2021. Retrieved 9 September 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  3. 1 2 3 4 "Cimerli- ranibizumab-eqrn injection, solution". DailyMed. 19 October 2022. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
  4. 1 2 3 4 "Ranivisio EPAR". European Medicines Agency (EMA). 20 June 2022. Archived from the original on 6 October 2022. Retrieved 6 October 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. 1 2 "Raniviz APMDS". Therapeutic Goods Administration (TGA). 8 January 2024. Archived from the original on 8 February 2024. Retrieved 7 March 2024.
  6. 1 2 3 "Susvimo- ranibizumab injection, solution". DailyMed. Archived from the original on 19 December 2021. Retrieved 19 December 2021.
  7. 1 2 3 "Ximluci EPAR". European Medicines Agency. 14 September 2022. Archived from the original on 13 March 2023. Retrieved 3 March 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. 1 2 "AusPAR: Ranibizumab". Therapeutic Goods Administration (TGA). 9 December 2014. Archived from the original on 21 September 2021. Retrieved 20 September 2021.
  9. 1 2 "Byooviz APMDS". Therapeutic Goods Administration (TGA). 6 September 2022. Retrieved 7 March 2024.
  10. "Summary Basis of Decision - Byooviz". Health Canada. 12 August 2022. Archived from the original on 29 September 2022. Retrieved 29 September 2022.
  11. "Summary Basis of Decision for Ranopto". Drug and Health Products Portal. 1 September 2012. Retrieved 23 July 2024.
  12. "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA . Retrieved 22 October 2023.
  13. 1 2 3 4 5 "Lucentis- ranibizumab injection, solution". DailyMed. Archived from the original on 21 September 2021. Retrieved 20 September 2021.
  14. 1 2 "Lucentis EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 10 September 2021. Retrieved 9 September 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  15. Heidary F, Hitam WH, Ngah NF, George TM, Hashim H, Shatriah I (March 2011). "Intravitreal Ranibizumab for Choroidal Neovascularization in Best's Vitelliform Macular Dystrophy in a 6-Year-Old Boy". Journal of Pediatric Ophthalmology and Strabismus. 48 Online (6): e19–e22. doi:10.3928/01913913-20110308-02. PMID   21417187. Archived from the original on 1 October 2021. Retrieved 1 October 2021.
  16. 1 2 "Lucentis Fact Sheet". Genentech. Archived from the original on 28 October 2012. Retrieved 28 October 2012.
  17. 1 2 "Drug Approval Package: Lucentis (Ranibizumab) NDA #125156". U.S. Food and Drug Administration (FDA). 26 September 2006. Archived from the original on 2 August 2022. Retrieved 2 August 2022.
  18. 1 2 "FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions". U.S. Food and Drug Administration (FDA) (Press release). 20 September 2021. Archived from the original on 20 September 2021. Retrieved 20 September 2021.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  19. Ramin S, Soheilian M, Habibi G, Ghazavi R, Gharebaghi R, Heidary F (2015). "Age-Related Macular Degeneration: A Scientometric Analysis". Medical Hypothesis, Discovery & Innovation in Ophthalmology. 4 (2): 39–49. PMC   4458325 . PMID   26060829.
  20. 1 2 Formoso G, Marata AM, Magrini N, Bero L (September 2014). Tovey D (ed.). "A clearer view of evidence in treating macular degeneration: off-label policies and independent research". The Cochrane Database of Systematic Reviews. 9 (9): ED000090. doi: 10.1002/14651858.ED000090 . PMC   10845851 . PMID   25228121.
  21. Solomon SD, Lindsley K, Vedula SS, Krzystolik MG, Hawkins BS (August 2014). "Anti-vascular endothelial growth factor for neovascular age-related macular degeneration". The Cochrane Database of Systematic Reviews. 8 (8): CD005139. doi:10.1002/14651858.CD005139.pub3. PMC   4270425 . PMID   25170575.
  22. Sarwar S, Clearfield E, Soliman MK, Sadiq MA, Baldwin AJ, Hanout M, et al. (February 2016). "Aflibercept for neovascular age-related macular degeneration". The Cochrane Database of Systematic Reviews. 2016 (2): CD011346. doi:10.1002/14651858.CD011346.pub2. PMC   5030844 . PMID   26857947.
  23. Virgili G, Curran K, Lucenteforte E, Peto T, Parravano M (June 2023). Cochrane Eyes and Vision Group (ed.). "Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis". The Cochrane Database of Systematic Reviews. 2023 (6): CD007419. doi:10.1002/14651858.CD007419.pub7. PMC   10294542 . PMID   38275741.
  24. "Susvimo Prescribing Information" (PDF). Genentech, Inc. Archived (PDF) from the original on 13 July 2024. Retrieved 23 July 2024.
  25. "Susvimo: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 3 August 2022. Retrieved 2 August 2022.
  26. 1 2 3 4 Moja L, Lucenteforte E, Kwag KH, Bertele V, Campomori A, Chakravarthy U, et al. (September 2014). Moja L (ed.). "Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration". The Cochrane Database of Systematic Reviews. 9 (9): CD011230. doi:10.1002/14651858.CD011230.pub2. PMC   4262120 . PMID   25220133.
  27. Schmucker C, Ehlken C, Agostini HT, Antes G, Ruecker G, Lelgemann M, et al. (2012). "A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard". PLOS ONE. 7 (8): e42701. Bibcode:2012PLoSO...742701S. doi: 10.1371/journal.pone.0042701 . PMC   3411814 . PMID   22880086.
  28. Haberfeld H, ed. (2009). Austria-Codex (in German) (2009/2010 ed.). Vienna: Österreichischer Apothekerverlag. ISBN   978-3-85200-196-8.[ page needed ]
  29. Ranibizumab Archived 29 August 2021 at the Wayback Machine , Lexi-Drugs. Ranibizumab. Lexi-Comp, Inc.; 2007.
  30. "ranibizumab". medscape. Archived from the original on 30 March 2015. Retrieved 24 March 2015.
  31. 1 2 Schmucker C, Ehlken C, Agostini HT, Antes G, Ruecker G, Lelgemann M, et al. (2012). "A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard". PLOS ONE. 7 (8): e42701. Bibcode:2012PLoSO...742701S. doi: 10.1371/journal.pone.0042701 . PMC   3411814 . PMID   22880086.
  32. Whoriskey P, Keating D (7 December 2013). "An effective eye drug is available for $50. But many doctors choose a $2,000 alternative". The Washington Post . Archived from the original on 26 January 2021. Retrieved 10 September 2017.
  33. 1 2 Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ (May 2011). "Ranibizumab and bevacizumab for neovascular age-related macular degeneration". The New England Journal of Medicine. 364 (20): 1897–1908. doi:10.1056/NEJMoa1102673. PMC   3157322 . PMID   21526923.
  34. Henderson D (17 June 2014). "Switch From Lucentis to Avastin Could Save Medicare $18B". Medscape. Archived from the original on 29 August 2021.
  35. Hutton D, Newman-Casey PA, Tavag M, Zacks D, Stein J (June 2014). "Switching to less expensive blindness drug could save medicare part B $18 billion over a ten-year period". Health Affairs. 33 (6): 931–939. doi:10.1377/hlthaff.2013.0832. PMC   4137040 . PMID   24889941.
  36. Pollack A (3 November 2010). "Genentech Offers Secret Rebates for Eye Drug". The New York Times . Archived from the original on 9 November 2020. Retrieved 25 February 2017.
  37. Subramanian ML, Abedi G, Ness S, Ahmed E, Fenberg M, Daly MK, et al. (November 2010). "Bevacizumab vs ranibizumab for age-related macular degeneration: 1-year outcomes of a prospective, double-masked randomised clinical trial". Eye. 24 (11): 1708–1715. doi: 10.1038/eye.2010.147 . PMID   20885427.
  38. Jiang S, Park C, Barner JC (June 2014). "Ranibizumab for age-related macular degeneration: a meta-analysis of dose effects and comparison with no anti-VEGF treatment and bevacizumab". Journal of Clinical Pharmacy and Therapeutics. 39 (3): 234–239. doi: 10.1111/jcpt.12146 . PMID   24635444. S2CID   23979022.
  39. Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Culliford LA, et al. (IVAN study investigators) (October 2013). "Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial". Lancet. 382 (9900): 1258–1267. doi: 10.1016/S0140-6736(13)61501-9 . PMID   23870813.
  40. "Byooviz Product information". Union Register of medicinal products. Archived from the original on 3 March 2023. Retrieved 3 March 2023.
  41. "Lupin receives CDSCO committee approval for marketing ranibizumab". www.pharmabiz.com. Archived from the original on 24 November 2021. Retrieved 24 November 2021.
  42. 1 2 "Ranivisio: Pending EC decision". European Medicines Agency. 22 June 2022. Archived from the original on 26 June 2022. Retrieved 26 June 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  43. "Ranivisio Product information". Union Register of medicinal products. Archived from the original on 3 March 2023. Retrieved 3 March 2023.
  44. "FDA Approves Coherus' Cimerli (ranibizumab-eqrn) as the First and Only Interchangeable Biosimilar to Lucentis for All Five Indications, with 12 Months of Interchangeability Exclusivity" (Press release). Coherus BioSciences. 2 August 2022. Archived from the original on 3 August 2022. Retrieved 2 August 2022 via GlobeNewswire News Room.
  45. 1 2 "Ximluci: Pending EC decision". European Medicines Agency (EMA). 15 September 2022. Archived from the original on 19 September 2022. Retrieved 18 September 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  46. "Ximluci Product information". Union Register of medicinal products. Archived from the original on 17 November 2022. Retrieved 3 March 2023.
  47. 1 2 3 "Rimmyrah: Pending EC decision". European Medicines Agency. 10 November 2023. Archived from the original on 13 November 2023. Retrieved 5 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  48. "FDA Approves Ranibizumab-eqrn Biosimilar, Interchangeable with Lucentis". Pharmacy Times. 3 August 2022. Archived from the original on 19 February 2023. Retrieved 22 January 2024.
  49. "Sandoz announces agreement to acquire Cimerli business from Coherus, strengthening position in US market". Sandoz (Press release). Archived from the original on 29 January 2024. Retrieved 22 January 2024.
  50. MarketScreener (22 January 2024). "Sandoz: acquisition of ophthalmology biosimilar". MarketScreener. Archived from the original on 10 March 2024. Retrieved 22 January 2024.