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- Xbrane Biopharma AB and JOINN Biologics US Inc. announced a strategic partnership to advance Xdarzane, a biosimilar candidate referencing Johnson & Johnson's multiple myeloma therapy Darzalex (daratumumab). - JOINN will lead pilot-scale process development and demonstrate analytical similarity, while Xbrane will spearhead global out-licensing and commercialization activities without additional direct development investment at this stage. - Darzalex generated approximately USD 14 billion in net sales in 2025, with loss of exclusivity expected in May 2029 in the US and 2031 in Europe, representing a substantial biosimilar market opportunity. - The collaboration combines Xbrane's biosimilar regulatory and partnering expertise with JOINN's integrated biologics development and manufacturing capabilities across US and China facilities.
- OneSource Specialty Pharma Limited has entered a strategic manufacturing partnership with Sweden-based Xbrane Biopharma AB to support commercial production of biosimilar products targeting EUR 23 billion in annual peak sales. - Xbrane's lead biosimilar candidate Ximluci, a ranibizumab biosimilar, has received European market authorization and launched in 2023, with U.S. approval currently under review. - The collaboration will involve technology transfer to OneSource's integrated biologics facility in Bangalore, India, while enabling regulatory approvals from the U.S. FDA and EMA for OneSource's manufacturing capabilities. - OneSource has also invested in Xbrane's recent funding round, demonstrating long-term strategic commitment between the two companies to expand global access to affordable biologics.
