FDA Approves First Ophthalmic Biosimilar With Samsung Bioepis’ Lucentis Rival
Byooviz Ranibizumab Biosimilar Approved; Company Reveals Launch Date Expectations
Samsung Bioepis has celebrated the FDA’s first ever approval of an ophthalmic biosimilar with its endorsement of the firm’s Byooviz ranibizumab rival to Lucentis. The firm has also signaled a surprising expected launch date in the US, as well as offering expectations for launch in Europe where the biosimilar was also recently approved.
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Looking back over a busy third quarter in 2021, Generics Bulletin executive editor David Wallace picks out highlights from July to September that include major legal and regulatory developments, multiple firsts in the biosimilars arena, significant M&A activity and our annual ranking of the off-patent sector’s top 50 companies.
Samsung Bioepis recently broke new ground with the first US approval for a biosimilar with ophthalmic indications. But, senior vice-president and development division leader Kyung-Ah Kim tells Generics Bulletin, there remains work to be done to ensure that ophthalmic biosimilars can meet their full potential.
The US FDA has accepted for review the CHS-201 Lucentis biosimilar product developed by Formycon/Bioeq that is to be sold in the US by Coherus BioSciences, shortly after approving the first ranibizumab biosimilar to treat wet age-related macular degeneration.