US Lucentis Competition Expectations Upended By Byooviz

Ranibizumab Biosimilar Competition Had Been Expected By End Of 2021 In US

Samsung Bioepis’ indication that it will not launch its FDA-approved ranibizumab biosimilar, Byooviz, before June 2022 has changed what we know about the competitive landscape for Lucentis in the US.

2021 2022 Roll Over Wooden Blocks
Biosimilar competition to Lucentis has rolled over to 2022 • Source: Alamy

When Samsung Bioepis announced the recent US Food and Drug Administration approval of its Byooviz (ranibizumab-nuna) biosimilar, the first approved US rival to Genentech’s Lucentis, a key detail was revealed by the company that could reshape expectations about US biosimilar competition to the ophthalmic brand.

Celebrating the FDA’s first approval of a biosimilar with ophthalmic indications – with the product approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization – the Samsung Bioepis joint venture between Samsung Biologics and Biogen revealed that “pursuant to a global license agreement entered into with Genentech, Samsung Bioepis and Biogen will have freedom to market SB11 in the US as of June 2022

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