On November 18, Samsung Bioepis and its marketing partner Biogen jointly announced that the 351(k) application for SB11, a ranibizumab biosimilar, has been filed and accepted by the Food and Drug Administration.
The US patent for Roche’s reference product Lucentis® expired in June 2020, and the market for ranibizumab could be over $1 billion. Lucentis has losing market share for the treatment of retinal vascular disorders to aflibercept over the past few years.
Although second to file for approval, Samsung Bioepis’ most prominent competitor experienced a setback earlier this year. In its third-quarter earnings report, Coherus Biosciences disclosed that it was preparing for “Bioeq’s resubmission of a 351(k) BLA with the FDA for the biosimilar candidate to Lucentis (ranibizumab) in 2021.” Coherus had previously indicated that its licensing partner Bioeq had filed for FDA approval in late 2019 but did not disclose an application rejection or other negative result. That could leave the door open for Samsung Bioepis and Biogen to launch first. Only one other biosimilar manufacturer has publicly announced an intent to market a ranibizumab biosimilar.
In its press release, Hee Kyung Kim, Senior Vice President and Clinical Sciences Division and Regulatory Affairs Team Leader, Samsung Bioepis, stated. “If approved, SB11 will be a valuable treatment option for people with retinal vascular disorders, potentially helping millions of people in the United States.”
Ian Henshaw, Senior Vice President and Global Head of Biosimilars at Biogen, called the 351(k) filing for SB11 “a key milestone in the process for providing a new potential treatment option for patients in the United States with retinal vascular disorders.” A drug approval application was also filed with the European Medicines Agency in October. The timing of this filing could place the FDA decision date in the late third quarter to early fourth quarter of 2021.