Samsung Bioepis Backed By EMA For First Lucentis Biosimilar

Byooviz Ranibizumab Biosimilar Recommended By EMA’s CHMP

Samsung Bioepis is set to make waves with the first ophthalmic biosimilar after the European regulator recommended that its ranibizumab biosimilar Byooviz receive a pan-European marketing authorization.

Eye
Byooviz will be sold in Europe by Biogen • Source: Shutterstock

Samsung Bioepis’ Byooviz (ranibizumab) biosimilar is set to become the first biosimilar referencing Lucentis (ranibizumab) to hit Europe, following a positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

The CHMP has announced it has recommended the European Commission grant Samsung Bioepis a landmark pan-European marketing authorization for its biosimilar treatment for wet age-related macular degeneration

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