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EMA accepts filing for Biogen/Samsung Bioepis’ Lucentis biosimilar

The European Medicines Agency (EMA) has accepted for review the marketing authorisation for Biogen and Samsung Bioepis’ biosimilar referencing Genentech’s Lucentis (ranibizumab).

The biosimilar – SB11 – is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders, which are a leading cause of blindness.

Back in November 2019, Samsung Bioepis announced that it had entered into a new commercialisation agreement for two ophthalmology biosimilar candidates – SB11 and SB15 (aflibercept), in the US, Canada, Europe, Japan and Australia.

If approved by the EMA, SB11 will join a growing number of biosimilars developed by Samsung Bioepis and commercialised by Biogen.

“The EMA filing acceptance for SB11 (ranibizumab) further demonstrates the productive collaboration between Samsung Bioepis and Biogen and brings us closer to our shared goal of offering new affordable treatment option for people with retinal vascular disorders,” said Hee Kyung Kim, senior vice president, clinical sciences and regulatory affairs division Lead, at Samsung Bioepis.

“The EMA acceptance of the SB11 (ranibizumab) application is an important step as we work to bring a new potential treatment option for patients with retinal vascular disorders and would represent a significant addition to our biosimilar portfolio,” said Ian Henshaw, senior vice president and global head of biosimilars at Biogen.

“We believe our biosimilar offerings are essential as we collaborate with payers and health authorities globally with the goal of creating budget headroom to fund innovation and ensure sustainable healthcare systems,” added Henshaw.