Samsung Bioepis, Biogen Announce FDA Filing Acceptance of Lucentis Biosimilar

Samsung Bioepis and Biogen announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for SB11, a proposed biosimilar referencing Lucentis® (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders, which are a leading cause of blindness in the United States.

Biosimilars are biological products that have been demonstrated to be similar in efficacy and safety to the originator’s reference product, with the advantage that they offer cost savings and promote sustainable access to therapies. Savings in the United States over the next five years as a result of biosimilars are projected to exceed $100 billion.

“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, at Samsung Bioepis. “If approved, SB11 will be a valuable treatment option for people with retinal vascular disorders, potentially helping millions of people in the United States.”

“We are encouraged by the FDA’s filing acceptance of SB11, a key milestone in the process for providing a new potential treatment option for patients in the United States with retinal vascular disorders,” said Ian Henshaw, Senior Vice President and Global Head of Biosimilars at Biogen. “Our biosimilar portfolio aims to ensure sustainability of healthcare systems by offering broader patient access to effective and more affordable treatment options.”

In October 2020, the Marketing Authorization Application (MAA) for SB11 was accepted for review by the European Medicines Agency (EMA). If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in Europe: BENEPALI™, IMRALDI™, and FLIXABI™.

Samsung Bioepis announced in November 2019 that it entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the United States, Canada, Europe, Japan and Australia.