FDA accepts BLA for Lucentis referencing ophthalmology biosimilar SB11

Samsung Bioepis and Biogen said that the US Food and Drug Administration (FDA) has accepted for review the biologics license application for SB11, a proposed ophthalmology biosimilar referencing Genentech’s Lucentis (ranibizumab).

Ranibizumab is an anti vascular endothelial growth factor (VEGF) therapy for retinal vascular disorders, which are a major cause of blindness in the US.

Hee Kyung Kim – Samsung Bioepis Senior Vice President and Clinical Sciences Division and Regulatory Affairs Team Leader said: “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.

“If approved, SB11 will be a valuable treatment option for people with retinal vascular disorders, potentially helping millions of people in the U.S.”

Samsung Bioepis has a commercialization agreement with Biogen in place for SB11 and another ophthalmology biosimilar candidate – SB15 (aflibercept) in the US, Canada, Europe, Australia, and Japan.

Ian Henshaw – Biogen Senior Vice President and Global Head of Biosimilars said: “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.

“Our biosimilar portfolio aims to ensure sustainability of healthcare systems by offering broader patient access to effective and more affordable treatment options.”

Last month, SB11’s marketing authorization application (MAA) was accepted for review by the European Medicines Agency (EMA). SB11, if approved, will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, which includes three anti-TNF biosimilars in Europe – BENEPALI, IMRALDI, and FLIXABI.