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EMA Begins Review of Samsung Bioepis' Ranibizumab


The European Medicines Agency (EMA) regulatory review advances a pact between Samsung Bioepis and Biogen announced last year.

The European Medicines Agency has initiated review of a proposed ranibizumab biosimilar (SB11) from Samsung Bioepis. The product candidate references Roche’s Lucentis and would treat retinal vascular disorders, a leading cause of blindness.

Samsung Bioepis developed the product and under a commercialization agreement announced in November 2019, Biogen will handle the marketing of both SB11 and an aflibercept biosimilar (SB15), which is an ophthalmology agent referencing Eylea, a Regeneron Pharmaceuticals/Bayer product. Biogen would manage sales of both products in the United States, Japan, Europe, Canada, and Australia.

“We believe SB11 has the potential to be a meaningful new offering for patients with retinal vascular disorders, and we look forward to continued engagement with the EMA throughout the review process,” Hee Kyung Kim, senior vice president for the Clinical Sciences and Regulatory Affairs Division at Samsung Bioepis, said in a statement.

Ranibizumab is an anti–vascular endothelial growth factor (VEGF) therapy that is used to block the excess development of blood vessels in the eye, which can contribute to the development of disease and tumor formation.

Aflibercept is used to treat wet macular degeneration and metastatic colorectal cancer. It is also an anti-VEGF product.

Samsung Bioepis is based in Incheon, Republic of Korea, and Biogen is in Cambridge, Massachusetts.

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