Samsung Bioepis achieved a milestone for US biosimilars in September, with the joint venture between Biogen and Samsung Biologics obtaining US Food and Drug Administration approval for its Byooviz (ranibizumab-nuna) SB11 candidate. This represented not only the first approved biosimilar to Genentech’s Lucentis in the US, but the first ever FDA approval of a biosimilar with ophthalmic indications. (Also see "FDA Approves First Ophthalmic Biosimilar With Samsung Bioepis’ Lucentis Rival" - Generics Bulletin, 20 September, 2021.)
Still ‘Work To Be Done’ After Ranibizumab Approval, Says Samsung Bioepis
Executive Kyung-Ah Kim Sees Opportunity To Lead On Ophthalmic Biosimilars
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.
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