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FDA Approves First Ophthalmic Biosimilar With Samsung Bioepis’ Lucentis Rival

Byooviz Ranibizumab Biosimilar Approved; Company Reveals Launch Date Expectations

Executive Summary

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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