As we have previously reported, on June 21, 2023, the FDA accepted Xbrane’s sBLA for LUCAMZI, a proposed ranibizumab biosimilar to Genentech’s LUCENTIS (ranibizumab). On October 16, 2025, Xbrane Biopharma AB announced that it has entered into a financing solution with Fenja Capital II A/S (Fenja) to proactively secure the company’s working capital needs in case of a delay in FDA approval of its ranibizumab biosimilar. According to XBrane, FDA approval was expected by October 21, 2025, and the loan of SEK 60 million will be triggered upon a delay in the FDA approval of the product.
To date, there are two FDA-approved ranibizumab biosimilars: Biogen/Samsung Bioepis’s BYOOVIZ (ranibizumab-nuna), approved in Sept. 2021 and Coherus’s CIMERLI (ranibizimab-egrn), approved in Aug. 2022.
Stay tuned to Big Molecule Watch for updates.