Shots:
- The US FDA has accepted the resubmitted BLA for Xbrane‘s Lucamzi, a biosimilar to Lucentis, & assigned a BsUFA action date of Oct 29, 2026
- The resubmission, completed in Apr 2026, addressed issues identified in the CRL received from the FDA in Oct 2025
- The product is already approved & marketed in EU as Ximluci, where it has been available since 2023 for the treatment of retinal disorders, & is intended to be commercialized in the US under the Lucamzi brand name
Ref: Xbrane | Image: Xbrane | Press Release
Related News: Xbrane Entered into an Agreement with Alvotech to sell XB003 (Biosimilar, Cimzia) and Parts of its Organization for ~$27.25M
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