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.

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