References
FDA approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab-nuna). https://investors.biogen.com/news-releases/news-release-details/fda-approves-samsung-bioepis-and-biogens-byooviztm-sb11. Accessed 7 Sept 2022.
Ranibizumab Biosimilar (Byooviz) Gains EU Marketing Authorization. https://www.centerforbiosimilars.com/view/samsung-bioepis-byooviz-gains-ema-marketing-authorization. Accessed 7 Sept 2022.
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. https://investors.coherus.com/news-releases/news-release-details/fda-approves-coherus-cimerlitm-ranibizumab-eqrn-first-and-only. Accessed 7 Sept 2022.
United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) grants marketing authorization for FYB201, Formycon’s biosimilar for Lucentis®¹, to be commercialized by Teva as ONGAVIA®. https://www.formycon.com/en/press-release/united-kingdom-medicines-and-healthcare-products-regulatory-agency-mhra-grants-marketing-authorization-for-fyb201-formycons-biosimilar-for-lucentis1-to-be-commercialized-by-teva-as-ongavia/. Accessed 7 Sept 2022.
European Commission approves FYB201/Ranivisio®1 (Ranivisio - Ranibizumab), a biosimilar to Lucentis. https://www.formycon.com/en/press-release/european-commission-approves-fyb201-ranivisio1-ranivisio-ranibizumab-a-biosimilar-to-lucentis2/. Accessed 7 Sept 2022.
Sharma A, Reddy P, Kuppermann BD, Bandello F, Lowenstein A. Biosimilars in ophthalmology: “Is there a big change on the horizon?”. Clin Ophthalmol. 2018;12:2137–43. https://doi.org/10.2147/OPTH.S180393.
Biosimilar and interchangeable biologics: more treatment choices. https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices#:~:text=An%20interchangeable%20biosimilar%20product%20may,subject%20to%20state%20pharmacy%20laws. Accessed 7 Sept 2022.
FDA approves Cyltezo, the first interchangeable biosimilar to Humira second interchangeable biosimilar product approved by agency. https://www.fda.gov/news-events/press-announcements/fda-approves-cyltezo-first-interchangeable-biosimilar-humira#:~:text=Cyltezo%20is%20the%20second%20interchangeable,for%20many%20serious%20health%20conditions. Accessed 7 Sept 2022.
Acknowledgements
BDK acknowledges an unrestricted grant from Research to Prevent Blindness to the Gavin Herbert Eye Institute at the University of California, Irvine.
Author information
Authors and Affiliations
Contributions
AS: conception, analysis, drafting, integrity check, and final approval. NK, NP, CR, FB and BDK: drafting, revision, analysis, and integrity check.
Corresponding author
Ethics declarations
Competing interests
AS: consultant for Novartis, Allergan, Bayer, and Intas. CR: consultant for Allergan, Chengdu Kanghong, Genentech/Roche, Novartis, Kodiak, Notal, Merck, Shire-Takeda, Adverum, Graybug, and Eyepoint and receives research support from Allergan, Chengdu Kanghong, Genentech/Roche, Novartis, Kodiak, Iveric, and Adverum. FB: consultant for Allergan, Bayer, Boehringer Ingelheim, FidiaSooft, Hofmann La Roche, Novartis, NTC Pharma, Sifi, ThromboGenics, and Zeiss. BDK: clinical research for Alcon, Alimera, Allegro, Allergan, Apellis, Clearside, Genentech, GSK, Ionis, jCyte, Novartis, Regeneron, and ThromboGenics; consultant for Alimera, Allegro, Allergan, Cell Care, Dose, Eyedaptic, Galimedix, Genentech, Glaukos, Interface Biologics, jCyte, Novartis, Ophthotech, Regeneron, Revana, and Theravance Biopharma. NK: none. NP: none.
Additional information
Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Sharma, A., Kumar, N., Parachuri, N. et al. Biosimilar ranibizumab interchangeability: what does it mean to retinal physicians?. Eye 37, 1953–1954 (2023). https://doi.org/10.1038/s41433-022-02287-w
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1038/s41433-022-02287-w
- Springer Nature Limited