Contract development and manufacturing organization (CDMO) OneSource Specialty Pharma Limited and Sweden-headquartered biotech company Xbrane Biopharma AB are partnering for the commercial manufacturing of Xbrane’s biosimilar portfolio, a note from OnceSource said.
Xbrane has a portfolio of biosimilar candidates targeting €23 billion in estimated annual peak sales, for the respective reference products, it added. The lead candidate Ximluci (a ranibizumab biosimilar) has and approval in Europe (launched in 2023) and is now under an approval process for the US, the company said. OneSource has also participated in Xbrane’s latest funding round, reinforcing their collaboration, it added.
As part of the agreement, Xbrane will undertake a tech-transfer of its commercial product to OneSource’s integrated drug substance and drug product (DS/DP) facility in Bengaluru. The collaboration aims to strengthen Xbrane’s global supply chain, while enabling OneSource to accelerate regulatory approvals, including from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), for its biologics drugs substance facility, the note said.
Neeraj Sharma, OnceSource Managing Director and Chief Executive said, Xbrane’s proven success in biosimilar development, combined with OneSource’s fully integrated biologics platform, creates a strong platform for global impact.
Martin Åmark, Chief Executive of Xbrane Biopharma, added: “Our partnership with OneSource gives us access to top-tier, cost-competitive manufacturing and expertise for our biosimilars. This is essential for our global competitiveness and our commitment to providing affordable medicines to patients and payers.”
Published on June 11, 2025
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