This is a preview of subscription content, access via your institution
Access options
Subscribe to this journal
Receive 18 print issues and online access
$259.00 per year
only $14.39 per issue
Rent or buy this article
Get just this article for as long as you need it
$39.95
Prices may be subject to local taxes which are calculated during checkout
References
FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab-nuna). 2022. https://investors.biogen.com/news-releases/news-release-details/fda-approves-samsung-bioepis-and-biogens-byooviztm-sb11.
Ranibizumab Biosimilar (Byooviz) Gains EU Marketing Authorization. 2022. https://www.centerforbiosimilars.com/view/samsung-bioepis-byooviz-gains-ema-marketing-authorization.
Woo SJ, Veith M, Hamouz J, Ernest J, Zalewski D, Studnicka J, et al. Efficacy and safety of a proposed ranibizumab biosimilar product vs a reference ranibizumab product for patients with neovascular age-related macular degeneration: a randomized clinical trial. JAMA Ophthalmol. 2021;139:68–76.
Bressler NM, Veith M, Hamouz J, Ernest J, Zalewski D, Studnicka J, et al. Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes. Br J Ophthalmol. 2021:bjophthalmol-2021-319637.
European Commission approves FYB201/Ranivisio®1 (Ranivisio—Ranibizumab), a biosimilar to Lucentis. 2022. https://www.formycon.com/en/press-release/european-commission-approves-fyb201-ranivisio1-ranivisio-ranibizumab-a-biosimilar-to-lucentis2/.
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®. 2022. 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/.
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. 2022. https://investors.coherus.com/news-releases/news-release-details/fda-approves-coherus-cimerlitm-ranibizumab-eqrn-first-and-only.
Holz FG, Oleksy P, Ricci F, Kaiser PK, Kiefer J, Schmitz-Valckenberg S, et al. Efficacy and safety of biosimilar FYB201 compared with ranibizumab in neovascular age-related macular degeneration. Ophthalmology. 2022;129:54–63.
Ranibizumab similar biologic launched in India. 2022. https://www.gabionline.net/biosimilars/news/Ranibizumab-similar-biologic-launched-in-India.
Apsangikar P, Ghadge P, Naik M, Nair S, Payghan R. Randomised, double-blind, comparative clinical study of new ranibizumab biosimilar in neovascular (wet) age-related macular degeneration. Clin Ophthalmol. 2021;15:3087–95.
Singh R, Chauhan R, Saxena A, Shah A, Mondal L, Bakhle D, et al. A prospective, randomized, parallel group, double blind, multicenter study to compare the efficacy, safety and immunogenicity of Lupin’s Ranibizumab with Lucentis® in patients with neovascular age-related macular degeneration. Indian J Ophthalmol. 2022;70:3008–14.
Acknowledgements
We would like to acknowledge help from Ira Steinberg, Coherus Biosciences, CA, USA, Alok Rasal, Intas pharmaceuticals, Ahmedabad, India and Oriol Mora Maltas, Biogen International GmbH, Baar, Switzerland for their contribution in sharing inputs on phase 3 data results of their products. 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, final approval. MK, CI, NP, NK, FB, AL, and BDK: drafting, revision, analysis, integrity check.
Corresponding author
Ethics declarations
Competing interests
AS: Consultant: for Novartis, Allergan, Bayer and Intas. MK: Clinical Research: Alcon, Bayer, Hoya, Kowa, Novartis, Otsuka, Santen, Senju; Consultant: Chugai, Daicel, Novartis, Ono, Sanofi, Asahi-Kasei, Senju. CI: none. FB: Consultant: Allergan, Bayer, Boehringer Ingelheim, FidiaSooft, Hofmann La Roche, Novartis, NTC Pharma, Sifi, Thrombogenics, Zeiss. AL reports other from Allergan, other from Novartis, other from Roche, other from Notal Vision, other from Forsightslabs, other from Beyeonics, other from Bayer Health Care. BDK: Clinical Research: Alimera, Allegro, Allergan, Apellis, Boehringer Ingelheim, Clearside, Genentech, GSK, Ionis, IvericBio, jCyte, Novartis, Regeneron; Consultant: Alimera, Allegro, Allergan, Eyebio, Eyedaptic, Galimedix, Genentech, Glaukos, Interface Biologics/Ripple Therapeutics, IvericBio, jCyte, Novartis, Regeneron, Revana, 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., Kondo, M., Iwahashi, C. et al. Approved biosimilar ranibizumab—a global update. Eye 37, 200–202 (2023). https://doi.org/10.1038/s41433-022-02246-5
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1038/s41433-022-02246-5