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Clinical Trials
0
0 active
Approvals
17
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
No trial phase data available
No trial data available
FDA
Food and Drug Administration
- 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.
