On 12 August 2024, Xbrane reported that it has commenced processes to out-license Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and XB003 (previously known as Xcimzane™, BIIB801), biosimilar to UCB’s Cimzia® (certolizumab pegol). The out-licensing process is to ensure “financing until envisioned positive operational cash-flow in Q2 2025”, including following the termination of Xbrane’s commercialisation and licensing agreement with Biogen earlier this month in relation to XB003.
Xbrane reports that initial discussions have been held with interested parties regarding the out-licensing of XB003 and it expects a licence agreement to be signed by the end of October 2024 at the latest. The out-licensing of Xcimzane™ is reportedly proving more difficult given likely high costs for phase 1 and 3 trials of the biosimilar. Xbrane says that it is seeking a streamlined clinical development plan for Xcimzane™ from regulatory authorities in Europe and the US.
On 21 April 2024, Xbrane announced that the FDA issued a Complete Letter Response regarding its ranibizumab BLA. Xbrane states it is working toward re-submitting the BLA for its ranibizumab biosmialr, Ximluci®, to FDA in Q4 2024. Xbrane and STADA announced the continental European launch of Ximluci® in April 2023.