ranibizumab
{{Short description|Pharmaceutical drug}}
{{Use dmy dates|date=July 2024}}
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{{Infobox drug
| Verifiedfields = changed
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| verifiedrevid = 464380069
| type = mab
| image =
| width =
| alt =
| caption =
| mab_type = Fab
| source = zu/o
| target = Vascular endothelial growth factor A (VEGF-A)
| pronounce =
| tradename = Lucentis, others
| Drugs.com = {{drugs.com|monograph|ranibizumab}}
| MedlinePlus = a607044
| DailyMedID = Ranibizumab
| pregnancy_AU = D
| pregnancy_AU_comment = {{cite web | title=Byooviz APMDS | website=Therapeutic Goods Administration (TGA) | date=6 September 2022 | url=https://www.tga.gov.au/resources/auspmd/byooviz | access-date=7 March 2024}}
| pregnancy_category=
| routes_of_administration = Intravitreal injection
| class =
| ATC_prefix = S01
| ATC_suffix = LA04
| ATC_supplemental =
| biosimilars = Byooviz, Cimerli, Epruvy, Ranivisio, Raniviz, Ranopto, Rimmyrah, Susvimo, Ximluci ranibizumab-eqrn, ranibizumab-nuna
| legal_AU = S4
| legal_AU_comment = {{cite web | title=AusPAR: Ranibizumab | website=Therapeutic Goods Administration (TGA) | date=9 December 2014 | url=https://www.tga.gov.au/auspar/auspar-ranibizumab-1 | access-date=20 September 2021 | archive-date=21 September 2021 | archive-url=https://web.archive.org/web/20210921062654/https://www.tga.gov.au/auspar/auspar-ranibizumab-1 | url-status=live }}{{cite web | title=Raniviz APMDS | website=Therapeutic Goods Administration (TGA) | date=8 January 2024 | url=https://www.tga.gov.au/resources/auspmd/raniviz | access-date=7 March 2024 | archive-date=8 February 2024 | archive-url=https://web.archive.org/web/20240208091930/https://www.tga.gov.au/resources/auspmd/raniviz | url-status=live }}
| legal_BR =
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA_comment = /{{nbsp}}Schedule D{{cite web | title=Summary Basis of Decision - Byooviz | website=Health Canada | date=12 August 2022 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00598&lang=en | access-date=29 September 2022 | archive-date=29 September 2022 | archive-url=https://web.archive.org/web/20220929042223/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00598&lang=en | url-status=live }}{{cite web | title=Summary Basis of Decision for Ranopto | website=Drug and Health Products Portal | date=1 September 2012 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1717516069966 | access-date=23 July 2024}}
| legal_DE =
| legal_DE_comment =
| legal_NZ =
| legal_NZ_comment =
| legal_UK = POM
| legal_UK_comment =
| legal_US = Rx-only
| legal_US_comment = {{cite web | title=Lucentis- ranibizumab injection, solution | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de4e66cc-ca05-4dc9-8262-e00e9b41c36d | access-date=20 September 2021 | archive-date=21 September 2021 | archive-url=https://web.archive.org/web/20210921055712/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de4e66cc-ca05-4dc9-8262-e00e9b41c36d | url-status=live }}{{cite web | title=Byooviz Nuna- ranibizumab injection, solution | website=DailyMed | date=27 April 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e46db299-edd1-4457-89b2-c1e2e505f1b0 | access-date=2 August 2022 | archive-date=3 August 2022 | archive-url=https://web.archive.org/web/20220803044308/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e46db299-edd1-4457-89b2-c1e2e505f1b0 | url-status=live }}{{cite web | title=Susvimo- ranibizumab injection, solution | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444 | access-date=19 December 2021 | archive-date=19 December 2021 | archive-url=https://web.archive.org/web/20211219214639/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444 | url-status=live }}{{cite web | title=Cimerli- ranibizumab-eqrn injection, solution | website=DailyMed | date=19 October 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e0e23118-1490-a554-e053-2995a90ab90c | access-date=21 January 2023 | archive-date=21 January 2023 | archive-url=https://web.archive.org/web/20230121062629/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e0e23118-1490-a554-e053-2995a90ab90c | url-status=live }}
| legal_EU = Rx-only
| legal_UN =
| legal_UN_comment =
| legal_status =
| bioavailability =
| protein_bound =
| metabolism =
| metabolites =
| onset =
| elimination_half-life = Approx. 9 days
| duration_of_action =
| excretion =
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 347396-82-1
| CAS_supplemental =
| PubChem =
| IUPHAR_ligand =
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB01270
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = none
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = ZL1R02VT79
| KEGG_Ref = {{keggcite|changed|kegg}}
| KEGG = D05697
| ChEBI_Ref =
| ChEBI =
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 1201825
| NIAID_ChemDB =
| PDB_ligand =
| synonyms =
| C=2158 | H=3282 | N=562 | O=681 | S=12
}}
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{{cite journal | vauthors = Heidary F, Hitam WH, Ngah NF, George TM, Hashim H, Shatriah I | title = Intravitreal Ranibizumab for Choroidal Neovascularization in Best's Vitelliform Macular Dystrophy in a 6-Year-Old Boy | journal = Journal of Pediatric Ophthalmology and Strabismus | volume = 48 Online | issue = 6 | pages = e19–e22 | date = March 2011 | pmid = 21417187 | doi = 10.3928/01913913-20110308-02 | url = https://journals.healio.com/doi/abs/10.3928/01913913-20110308-02 | access-date = 1 October 2021 | url-status = live | archive-url = https://web.archive.org/web/20211001185206/https://journals.healio.com/doi/abs/10.3928/01913913-20110308-02 | archive-date = 1 October 2021 | url-access = subscription }} 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.
Ranibizumab was developed by Genentech and marketed by them in the United States, and elsewhere by Novartis,{{cite web | title=Lucentis Fact Sheet | website=Genentech | url=https://www.gene.com/gene/products/information/tgr/lucentis/factsheet.html | access-date=28 October 2012 | archive-url=https://web.archive.org/web/20121028214234/http://www.gene.com/gene/products/information/tgr/lucentis/factsheet.html | archive-date=28 October 2012 }} under the brand name Lucentis. Ranibizumab (Lucentis) was approved for medical use in the United States in June 2006,{{cite web | title=Drug Approval Package: Lucentis (Ranibizumab) NDA #125156 | website=U.S. Food and Drug Administration (FDA) | date=26 September 2006 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125156s0000_LucentisTOC.cfm | access-date=2 August 2022 | archive-date=2 August 2022 | archive-url=https://web.archive.org/web/20220802102442/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125156s0000_LucentisTOC.cfm | url-status=dead }} 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.
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.
It is used for age-related wet macular degeneration.{{cite journal | vauthors = Ramin S, Soheilian M, Habibi G, Ghazavi R, Gharebaghi R, Heidary F | title = Age-Related Macular Degeneration: A Scientometric Analysis | journal = Medical Hypothesis, Discovery & Innovation in Ophthalmology | volume = 4 | issue = 2 | pages = 39–49 | date = 2015 | pmid = 26060829 | pmc = 4458325 }} Its effectiveness is similar to that of bevacizumab{{cite journal | vauthors = Solomon SD, Lindsley K, Vedula SS, Krzystolik MG, Hawkins BS | title = Anti-vascular endothelial growth factor for neovascular age-related macular degeneration | journal = The Cochrane Database of Systematic Reviews | volume = 8 | issue = 8 | pages = CD005139 | date = August 2014 | pmid = 25170575 | pmc = 4270425 | doi = 10.1002/14651858.CD005139.pub3 }} and aflibercept.{{cite journal | vauthors = Sarwar S, Clearfield E, Soliman MK, Sadiq MA, Baldwin AJ, Hanout M, Agarwal A, Sepah YJ, Do DV, Nguyen QD | title = Aflibercept for neovascular age-related macular degeneration | journal = The Cochrane Database of Systematic Reviews | volume = 2016 | issue = 2 | pages = CD011346 | date = February 2016 | pmid = 26857947 | pmc = 5030844 | doi = 10.1002/14651858.CD011346.pub2 }} 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.{{cite journal | vauthors = Virgili G, Curran K, Lucenteforte E, Peto T, Parravano M | title = Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis | journal = The Cochrane Database of Systematic Reviews | volume = 2023 | issue = 6 | pages = CD007419 | date = June 2023 | pmid = 38275741 | pmc = 10294542 | doi = 10.1002/14651858.CD007419.pub7 | collaboration = Cochrane Eyes and Vision Group }}
Susvimo is a reformulation of ranibizumab suitable for injection via ocular implant.{{Cite web |title=Susvimo Prescribing Information |url=https://www.gene.com/download/pdf/susvimo_prescribing.pdf |url-status=live |archive-url=https://web.archive.org/web/20240713230751/https://www.gene.com/download/pdf/susvimo_prescribing.pdf |archive-date=13 July 2024 |access-date=23 July 2024 |website=Genentech, Inc.}} Susvimo was approved for medical use in the United States in October 2021.{{cite web |title=Susvimo: FDA-Approved Drugs |url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761197 |url-status=dead |archive-url=https://web.archive.org/web/20220803044308/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761197 |archive-date=3 August 2022 |access-date=2 August 2022 |website=U.S. Food and Drug Administration (FDA)}}
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.{{cite journal | vauthors = Moja L, Lucenteforte E, Kwag KH, Bertele V, Campomori A, Chakravarthy U, D'Amico R, Dickersin K, Kodjikian L, Lindsley K, Loke Y, Maguire M, Martin DF, Mugelli A, Mühlbauer B, Püntmann I, Reeves B, Rogers C, Schmucker C, Subramanian ML, Virgili G | veditors = Moja L | title = Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration | journal = The Cochrane Database of Systematic Reviews | volume = 9 | issue = 9 | pages = CD011230 | date = September 2014 | pmid = 25220133 | pmc = 4262120 | doi = 10.1002/14651858.CD011230.pub2 }} There, however, was not a lot of evidence, and thus this conclusion is not that certain.
Ranibizumab does appear to result in a lower risk of stomach and intestinal problems. It is also associated with a low rate of eye related side effects.{{cite journal | vauthors = Schmucker C, Ehlken C, Agostini HT, Antes G, Ruecker G, Lelgemann M, Loke YK | title = A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard | journal = PLOS ONE | volume = 7 | issue = 8 | pages = e42701 | date = 2012 | pmid = 22880086 | pmc = 3411814 | doi = 10.1371/journal.pone.0042701 | doi-access = free | bibcode = 2012PLoSO...742701S }}
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.{{cite book|title=Austria-Codex| veditors = Haberfeld H |publisher=Österreichischer Apothekerverlag|location=Vienna|year=2009|edition=2009/2010|isbn=978-3-85200-196-8|language=de}}{{Page needed|date=July 2011}}
Interactions
Pharmacology
Ranibizumab is a monoclonal antibody that inhibits angiogenesis by inhibiting vascular endothelial growth factor A, a mechanism similar to that of bevacizumab.{{cite web |url=http://reference.medscape.com/drug/lucentis-ranibizumab-343645#10 |title=ranibizumab |website=medscape |access-date=24 March 2015 |archive-date=30 March 2015 |archive-url=https://web.archive.org/web/20150330025844/http://reference.medscape.com/drug/lucentis-ranibizumab-343645#10 |url-status=live }}
Society and culture
= Legal status =
== Biosimilars ==
{{see also|Biosimilars}}
Byooviz was authorized for medical use in the European Union in August 2021.{{cite web | title=Byooviz EPAR | website=European Medicines Agency | date=23 June 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/byooviz | access-date=9 September 2021 | archive-date=10 September 2021 | archive-url=https://web.archive.org/web/20210910053259/https://www.ema.europa.eu/en/medicines/human/EPAR/byooviz | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.{{cite web | title=Byooviz Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1572.htm | access-date=3 March 2023 | archive-date=3 March 2023 | archive-url=https://web.archive.org/web/20230303201354/https://ec.europa.eu/health/documents/community-register/html/h1572.htm | url-status=live }}
Ranibizumab-nuna (Byooviz) was approved for medical use in the United States in September 2021.{{cite press release | title=FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions | website=U.S. Food and Drug Administration (FDA) | date=20 September 2021 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-macular-degeneration-disease-and-other-eye-conditions | access-date=20 September 2021 | archive-date=20 September 2021 | archive-url=https://web.archive.org/web/20210920183653/https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-macular-degeneration-disease-and-other-eye-conditions | url-status=dead }} {{PD-notice}}
In India, Lupin Limited received marketing approval for its biosimilar of Ranibizumab.{{cite web|title=Lupin receives CDSCO committee approval for marketing ranibizumab|url=http://www.pharmabiz.com/NewsDetails.aspx?aid=139853&sid=1|access-date=24 November 2021|website=www.pharmabiz.com|archive-date=24 November 2021|archive-url=https://web.archive.org/web/20211124102131/http://www.pharmabiz.com/NewsDetails.aspx?aid=139853&sid=1|url-status=live}}
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. The applicant for this medicinal product is Midas Pharma GmbH.{{cite web | title=Ranivisio: Pending EC decision | website=European Medicines Agency | date=22 June 2022 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/ranivisio | access-date=26 June 2022 | archive-date=26 June 2022 | archive-url=https://web.archive.org/web/20220626025455/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/ranivisio | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Ranivisio was authorized for medical use in the European Union in August 2022.{{cite web | title=Ranivisio EPAR | website=European Medicines Agency (EMA) | date=20 June 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ranivisio | access-date=6 October 2022 | archive-date=6 October 2022 | archive-url=https://web.archive.org/web/20221006034343/https://www.ema.europa.eu/en/medicines/human/EPAR/ranivisio | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.{{cite web | title=Ranivisio Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1673.htm | access-date=3 March 2023 | archive-date=3 March 2023 | archive-url=https://web.archive.org/web/20230303201334/https://ec.europa.eu/health/documents/community-register/html/h1673.htm | url-status=live }}
Ranibizumab-eqrn (Cimerli) was approved for medical use in the United States in August 2022.{{cite press release | title=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 | publisher=Coherus BioSciences | via=GlobeNewswire News Room | date=2 August 2022 | url=https://www.globenewswire.com/news-release/2022/08/02/2490955/33333/en/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.html | access-date=2 August 2022 | archive-date=3 August 2022 | archive-url=https://web.archive.org/web/20220803044308/https://www.globenewswire.com/news-release/2022/08/02/2490955/33333/en/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.html | url-status=live }}
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. The applicant for this medicinal product is STADA Arzneimittel AG.{{cite web | title=Ximluci: Pending EC decision | website=European Medicines Agency (EMA) | date=15 September 2022 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/ximluci | access-date=18 September 2022 | archive-date=19 September 2022 | archive-url=https://web.archive.org/web/20220919032022/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/ximluci | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Ximluci was authorized for medical use in the European Union in November 2022.{{cite web | title=Ximluci EPAR | website=European Medicines Agency | date=14 September 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ximluci | access-date=3 March 2023 | archive-date=13 March 2023 | archive-url=https://web.archive.org/web/20230313235137/https://www.ema.europa.eu/en/medicines/human/EPAR/ximluci | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.{{cite web | title=Ximluci Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1691.htm | access-date=3 March 2023 | archive-date=17 November 2022 | archive-url=https://web.archive.org/web/20221117235142/https://ec.europa.eu/health/documents/community-register/html/h1691.htm | url-status=live }}
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. The applicant for this medicinal product is QILU PHARMA SPAIN S.L.{{cite web | title=Rimmyrah: Pending EC decision | website=European Medicines Agency | date=10 November 2023 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/rimmyrah | access-date=5 December 2023 | archive-date=13 November 2023 | archive-url=https://web.archive.org/web/20231113193718/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/rimmyrah | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. 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. Rimmyrah was authorized for medical use in the European Union in January 2024.{{cite web | title=Rimmyrah EPAR | website=European Medicines Agency (EMA) | date=5 January 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/rimmyrah | access-date=7 September 2024}}{{cite web | title=Rimmyrah PI | website=Union Register of medicinal products | date=9 January 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1779.htm | access-date=7 September 2024}}
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}}.{{cite web |date=3 August 2022 |title=FDA Approves Ranibizumab-eqrn Biosimilar, Interchangeable with Lucentis |url=https://www.pharmacytimes.com/view/fda-approves-ranibizumab-eqrn-biosimilar-interchangeable-with-lucentis |access-date=22 January 2024 |website=Pharmacy Times |archive-date=19 February 2023 |archive-url=https://web.archive.org/web/20230219010652/https://www.pharmacytimes.com/view/fda-approves-ranibizumab-eqrn-biosimilar-interchangeable-with-lucentis |url-status=live }}{{cite press release | title=Sandoz announces agreement to acquire Cimerli business from Coherus, strengthening position in US market | url=https://www.sandoz.com/sandoz-announces-agreement-acquire-cimerlir-business-coherus-strengthening-position-us-market/ | access-date=22 January 2024 | website=Sandoz | archive-date=29 January 2024 | archive-url=https://web.archive.org/web/20240129042733/https://www.sandoz.com/sandoz-announces-agreement-acquire-cimerlir-business-coherus-strengthening-position-us-market/ | url-status=live }}{{cite web |date=22 January 2024 |title=Sandoz: acquisition of ophthalmology biosimilar |url=https://www.marketscreener.com/quote/stock/SANDOZ-GROUP-AG-160016887/news/Sandoz-acquisition-of-ophthalmology-biosimilar-45782186/ |access-date=22 January 2024 |website=MarketScreener |archive-date=10 March 2024 |archive-url=https://web.archive.org/web/20240310055918/https://www.marketscreener.com/quote/stock/SANDOZ-GROUP-AG-160016887/news/Sandoz-acquisition-of-ophthalmology-biosimilar-45782186/ |url-status=live }}
In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Epruvy, 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 and visual impairment due to choroidal neovascularization. The applicant for this medicinal product is Midas Pharma GmbH. Epruvy is a biosimilar medicinal product and is a duplicate of Ranivisio.{{cite web | title=Epruvy EPAR | website=European Medicines Agency | date=25 July 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ranibizumab-midas | access-date=27 July 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Epruvy was authorized for medical use in the European Union in September 2024.{{cite web | title=Epruvy PI | website=Union Register of medicinal products | date=24 September 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1860.htm | access-date=4 March 2025}}
= Economics =
Its effectiveness is similar to that of bevacizumab.{{cite journal | vauthors = Formoso G, Marata AM, Magrini N, Bero L | veditors = Tovey D | title = A clearer view of evidence in treating macular degeneration: off-label policies and independent research | journal = The Cochrane Database of Systematic Reviews | volume = 9 | issue = 9 | pages = ED000090 | date = September 2014 | pmid = 25228121 | doi = 10.1002/14651858.ED000090 | doi-access = free | pmc = 10845851 }}{{cite journal | vauthors = Schmucker C, Ehlken C, Agostini HT, Antes G, Ruecker G, Lelgemann M, Loke YK | title = A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard | journal = PLOS ONE | volume = 7 | issue = 8 | pages = e42701 | year = 2012 | pmid = 22880086 | pmc = 3411814 | doi = 10.1371/journal.pone.0042701 | doi-access = free | bibcode = 2012PLoSO...742701S }} Its rates of side effects also appear similar. However, ranibizumab typically costs $2,000 a dose, while the equivalent dose of bevacizumab typically costs $50.{{cite news | url = https://www.washingtonpost.com/business/economy/an-effective-eye-drug-is-available-for-50-but-many-doctors-choose-a-2000-alternative/2013/12/07/1a96628e-55e7-11e3-8304-caf30787c0a9_story.html?hpid=z1
| title = An effective eye drug is available for $50. But many doctors choose a $2,000 alternative. | newspaper = The Washington Post | date = 7 December 2013 | vauthors = Whoriskey P, Keating D | access-date = 10 September 2017 | archive-date = 26 January 2021 | archive-url = https://web.archive.org/web/20210126122745/https://www.washingtonpost.com/business/economy/an-effective-eye-drug-is-available-for-50-but-many-doctors-choose-a-2000-alternative/2013/12/07/1a96628e-55e7-11e3-8304-caf30787c0a9_story.html?hpid=z1 | url-status = live }}{{cite web | url = http://www.medscape.com/viewarticle/826911_print | title = Switch From Lucentis to Avastin Could Save Medicare $18B | archive-url = https://web.archive.org/web/20210829025723/https://www.medscape.com/viewarticle/826911_print | archive-date=29 August 2021 | vauthors = Henderson D | work = Medscape | date = 17 June 2014 }}{{cite journal | vauthors = Hutton D, Newman-Casey PA, Tavag M, Zacks D, Stein J | title = Switching to less expensive blindness drug could save medicare part B $18 billion over a ten-year period | journal = Health Affairs | volume = 33 | issue = 6 | pages = 931–939 | date = June 2014 | pmid = 24889941 | pmc = 4137040 | doi = 10.1377/hlthaff.2013.0832 }}
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.{{cite news | url = https://www.nytimes.com/2010/11/04/business/04eye.html | title = Genentech Offers Secret Rebates for Eye Drug | work = The New York Times | vauthors = Pollack A | date = 3 November 2010 | access-date = 25 February 2017 | archive-date = 9 November 2020 | archive-url = https://web.archive.org/web/20201109042845/http://www.nytimes.com/2010/11/04/business/04eye.html | url-status = live }} A small study showed no superior effect of ranibizumab versus bevacizumab in direct comparison.{{cite journal | vauthors = Subramanian ML, Abedi G, Ness S, Ahmed E, Fenberg M, Daly MK, Houranieh A, Feinberg EB | title = Bevacizumab vs ranibizumab for age-related macular degeneration: 1-year outcomes of a prospective, double-masked randomised clinical trial | journal = Eye | volume = 24 | issue = 11 | pages = 1708–1715 | date = November 2010 | pmid = 20885427 | doi = 10.1038/eye.2010.147 | doi-access = free }} 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.{{cite journal | vauthors = Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ | title = Ranibizumab and bevacizumab for neovascular age-related macular degeneration | journal = The New England Journal of Medicine | volume = 364 | issue = 20 | pages = 1897–1908 | date = May 2011 | pmid = 21526923 | pmc = 3157322 | doi = 10.1056/NEJMoa1102673 }}
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.{{cite journal | vauthors = Jiang S, Park C, Barner JC | title = Ranibizumab for age-related macular degeneration: a meta-analysis of dose effects and comparison with no anti-VEGF treatment and bevacizumab | journal = Journal of Clinical Pharmacy and Therapeutics | volume = 39 | issue = 3 | pages = 234–239 | date = June 2014 | pmid = 24635444 | doi = 10.1111/jcpt.12146 | s2cid = 23979022 | doi-access = free }}{{cite journal | vauthors = Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Culliford LA, Reeves BC | title = Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial | journal = Lancet | volume = 382 | issue = 9900 | pages = 1258–1267 | date = October 2013 | pmid = 23870813 | doi = 10.1016/S0140-6736(13)61501-9 | collaboration = IVAN study investigators | doi-access = free }} 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.
References
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Category:Angiogenesis inhibitors
Category:Drugs developed by Genentech
Category:Drugs developed by Hoffmann-La Roche
Category:Monoclonal antibodies