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Update on Xbrane Out-Licensing Nivolumab & Certolizumab Biosimilars

Oct 21, 2024

In August 2024, Xbrane commenced its out-licensing process for Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and XB003 (previously known as Xcimzane™, BIIB801), biosimilar to UCB’s Cimzia® (certolizumab pegol).

On 21 October 2024, Xbrane announced it reached agreement negotiation stage with Xdivane™ and received the first non-binding proposals on XB003.  The previous expectation of concluding an agreement by the end of October 2024 has not been met.  This has been extended to the end of November 2024 when a final agreement and an expected upfront payment are needed to fulfil the company’s working capital requirements.

Xbrane reports that its Xdivane™ out-licensing process will enable a launch upon Loss of Exclusivity for BMS’ Opdivo® in the USA in December 2028.  Opdivo® achieved sales of approximately USD $8 billion globally during 2023.  Xbrane reports its scale-up of the drug substance production process is completed to commercial scale, analytical similarity to the reference product demonstrated and scientific advice on a streamlined clinical development plan has now been received from both EMA and FDA.

Xbrane also reports it has received the first non-binding proposals on XB003.  Xbrane says it has successfully scaled up the production process to clinical scale, analytical similarity to the reference product has been demonstrated and scientific advice with EMA and FDA on the clinical development plan is expected in Q1 2025.  Again, the previous expectation of a licence agreement being concluded by the end of October 2024 has not been met.