The US FDA approved the first ranibizumab biosimilar, developed by Samsung Bioepis. The biosimilar with tradename Byooviz, references Lucentis® for the treatment of several ophthalmological conditions such as neovascular (wet) age-related macular degeneration (AMD), macular edema, retinal vein occlusion, and myopic choroidal neovascularization. This US FDA approval follows soon after the EMA approval two weeks back. The US FDA and EMA approvals also mark the entry of the first biosimilar for ophthalmology indications. Due to existing agreement between the innovator Genentech and Samsung Bioepis, the drug will not be launched in the market before June 2022.
Samsung Bioepis and Biogen entered into a commercialization partnership for the biosimilar in November 2019 and Biogen will be responsible for marketing the drug in USA, Canada, Europe, Japan and Australia. The approval marks the fifth biosimilar for Samsung Bioepis in the US market along with infliximab, trastuzumab, etanercept, and adalimumab.
Lucentis® is one of the blockbuster drugs in the ophthalmology segment and in 2020 clocked in USD 1.93 billion in global sales. Other than ranibizumab, bevacizumab (Avastin) is used off-label for certain eye conditions. However, with the introduction of an approved biosimilar, off-label use of bevacizumab could come down with a more affordable ranibizumab biosimilar. Other biosimilars in the pipeline are by Chong Kun Dang Pharmaceutical, Coherus Biosciences, Intas Pharmaceuicals, Xbrane/ STADA, Siam Biosciences et al. Teva and Bioeq also entered into a marketing partnership for Bioeq’s ranibizumab biosimilar earlier this year.