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FDA Accepts Ranibizumab BLA From Samsung Bioepis and Biogen


The FDA's acceptance of the biologics license application (BLA) moves the companies one step closer to entering the US ophthalmology treatment sphere with a biosimilar.

Samsung Bioepis and Biogen said the FDA has accepted for review their biologics license application for a ranibizumab biosimilar candidate (SB11), referencing Lucentis, a Genentech product. The drug is an anti–vascular endothelial growth factor treatment for retinal vascular disorders, a leading cause of blindness.

SB11 was developed by Samsung Bioepis and Biogen is the commercialization partner, according to an agreement the companies signed in November 2019.

“The FDA filing acceptance for SB11 brings us a step closer to our goal of being able to offer affordable treatment options for people with retinal vascular disorders,” said Hee Kyung Kim, senior vice president and Clinical Sciences Division and Regulatory Affairs team leader for Samsung Bioepis.

The European Medicines Agency accepted the marketing application for SB11 in October 2020. The corporate partners already market several biosimilars on the European market, including an etanercept (Benepali), adalimumab (Imraldi), and infliximab (Flixabi).

Samsung Bioepis and Biogen also plan to bring an aflibercept biosimilar (SB15) to market in the United States, Canada, Europe, Japan, and Australia. In the United States, aflibercept (Eylea) is indicated for the treatment of macular degeneration, macular edema, and diabetic retinopathy.

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