Samsung Bioepis and Biogen's EMA filing for Lucentis biosimilar accepted

6 October 2020

South Korea’s Samsung Bioepis and Biogen (Nasdaq: BIIB) today announced that the European Medicines Agency (EMA) has accepted for review its Marketing Authorization Application for SB11, a proposed biosimilar referencing Lucentis (ranibizumab).

Lucentis was developed by the Roche (ROG: SIX) unit Genentech, which markets the product in the USA, while marketing rights elsewhere are held by Novartis (NOVN: VX), and generated sale of $401 million in the second-quarter of 2020 for the Swiss giant.

Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness. If approved, SB11 will join a growing number of biosimilars developed by Samsung Bioepis, a joint venture between South Korea’s Samsung BioLogics and US biotech major Biogen and commercialized by Biogen.

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