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.

Eye USA Flag Face
Samsung Bioepis recently gained the first US ophthalmic biosimilar approval • Source: Alamy

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.)

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