Xbrane Biopharma AB (publ) ("Xbrane" or the "Company"), a biotechnology company specializing in biosimilars, today announced that the pivotal clinical trial for Xdivane™, the Company’s biosimilar candidate to Opdivo® (nivolumab), has achieved full patient recruitment.
Approximately 340 patients with melanoma have been enrolled in the study, marking a significant milestone for the Xdivane development program. Xdivane is being co-developed with Xbrane’s strategic partner Intas Pharmaceuticals Ltd. Under the parties’ global license agreement, Intas is responsible for the clinical development of Xdivane and, through its commercial arm Accord Healthcare, global commercialization.
“This is an important achievement for the Xdivane program and a testament to the commitment of patients, investigators, clinical sites and the entire Xbrane team,” said Martin Åmark, CEO of Xbrane Biopharma. We now look forward to generating the clinical and analytical data required to support regulatory submissions and advance Xdivane toward commercialization.”
Opdivo® (nivolumab), developed by Bristol Myers Squibb, is one of the largest oncology biologics globally, with 2025 worldwide sales of approximately USD 10.0 billion according to Bristol Myers Squibb’s reported product revenues.
About Xdivane™
Xdivane is Xbrane’s biosimilar candidate to Opdivo® (nivolumab), a PD-1 immune checkpoint inhibitor approved for the treatment of multiple cancers, including melanoma, non-small cell lung cancer, renal cell carcinoma and several additional tumor types. The development program is designed to establish biosimilarity through a comprehensive analytical, non-clinical and clinical package in accordance with regulatory requirements.