Partners Samsung Bioepis and Biogen announced today in a press release that their 351(k) application for its ranibizumab biosimilar (reference product, Lucentis®) gained approval from the Food and Drug Administration. Dubbed Byooviz™, this injectable product is the first biosimilar to be approved for ophthalmologic indications.
Formerly referred to as SB11 and now designated ranibizumab-nuna, the drug approval includes the following indications:
- Neovascular (wet) age-related macular degeneration (AMD)
- Macular edema following retinal vein occlusion (RVO)
- Myopic choroidal neovascularization (mCNV)
In August, Byooviz gained approval in the EU and in the United Kingdom. “In the United States, approximately 11 million people are affected with AMD and the prevalence of advanced AMD is growing due to the aging population. The approval of the first ranibizumab biosimilar in the US is a monumental milestone for people living with retinal vascular disorders in the US,” said Kyung-Ah Kim, Senior Vice President and Development Division Leader, at Samsung Bioepis. “The approval of Byooviz underscores our continued commitment to providing valuable treatment options for people who do not have access to life-enhancing biologic medicines around the world,” she added.
The 351(k) application was first filed November 18, 2020. Under their commercialization agreement, Biogen will market Byooviz in the US. Another Samsung Bioepis ophthalmology biosimilar, SB15 (aflibercept), will be subject to the same arrangement once FDA approval is achieved.
Don’t expect to see the launch of Byooviz anytime soon, however. Samsung Bioepis also disclosed that it had signed a licensing agreement with Genentech (Roche), which prohibits the partners from marketing the drug in the US until June 2022 (“before expiration of Genentech’s applicable supplementary patent certificates”), according to the press release. The main US patent for Lucentis expired in June 2020.
Although the US market for ranibizumab has dipped because of competition from compounded bevacizumab and loss of share to aflibercept (Eylea®), the market for ranibizumab could still be over $1 billion. The FDA approval of Byooviz was based in part on the results of a multicenter Phase 3 study of SB11 versus Lucentis in patients with wet AMD. The results were positive for the biosimilar and demonstrated no significant differences in pharmacokinetics, safety, or immunogenicity between the two comparators through week 52.
The ophthalmologic biosimilars will be a highly competitive market, with upcoming biosimilars for not only ranibizumab, but also for aflibercept, and the potential for a manufactured version of bevacizumab for ophthalmology indications. Furthermore, Genentech is introducing a new port-delivery system that could affect the need for monthly intravitreal injections.