On June 21, 2023, Xbrane announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Xbrane’s supplemental Biologics License Application (sBLA) for a LUCENTIS® (ranibizumab) biosimilar candidate. Xbrane stated that “[t]he biosimilar candidate is a VEGF-a inhibitor, intended for the treatment of serious eye diseases such as wet age-related macular degeneration (wAMD), macular edema following retinal vein occlusion and myopic choroidal neovascularization.” The biosimilar candidate was co-developed by Xbrane and STADA, and the two companies granted Bausch + Lomb an exclusive license to commercialize the biosimilar candidate in the United States and Canada.
There are currently two FDA-approved biosimilars to LUCENTIS®: Biogen and Samsung Bioepis’s BYOOVIZ® (ranibizumab-nuna) and Coherus’s CIMERLI® (ranibizumab-eqrn).
The FDA set a Biosimilar User Fee Amendment (BsUFA) goal date of April 21st, 2024.