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FDA Approves First Ophthalmic Biosimilar With Samsung Bioepis’ Lucentis Rival

Byooviz Ranibizumab Biosimilar Approved; Company Reveals Launch Date Expectations

 
• By Dave Wallace

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.

OK Sign Eye Woman
The FDA has approved the Byooviz ranibizumab biosimilar to Lucentis • Source: Alamy

Samsung Bioepis has seen its Byooviz (ranibizumab-nuna) biosimilar to Genentech’s Lucentis approved by the US Food and Drug Administration, marking the agency’s first ever approval of a biosimilar with ophthalmic indications.

At the same time, the joint venture between Samsung Biologics and Biogen has revealed launch date expectations for the SB11 product, both in the US – where the firm indicated that a settlement with the originator means the biosimilar will not launch until June next year – as well as in Europe where it was also recently approved

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