OneSource and Xbrane Biopharma enter into strategic biosimilars manufacturing partnership for global markets

New Delhi: OneSource Specialty Pharma Limited, multi-modality specialty pharma pure-play CDMO, and Xbrane Biopharma AB, a Sweden-headquartered biotechnology company, have announced a strategic partnership focused on the commercial manufacturing of Xbrane’s biosimilar portfolio.

Xbrane has a portfolio of biosimilar candidates targeting EUR 23 billion in estimated annual peak sales of the respective reference products. The lead candidate Ximluci (a ranibizumab biosimilar) is granted market authorization approval in Europe (launched in 2023) and is now under the approval process for the US launch.

As part of the agreement, Xbrane will tech transfer its commercial product (Tech Transfer) to OneSource’s state-of-the-art integrated Drug Substance and Drug Product (DS/DP) facility in Bangalore, India. The collaboration aims to strengthen Xbrane’s global supply chain, while enabling OneSource to accelerate regulatory approvals, including from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), for its biologics drugs substance facility. As part of the collaboration, OneSource has also participated in Xbrane’s latest funding round, reinforcing the long-term strategic alignment between the two companies.

Neeraj Sharma, Managing Director & CEO of OneSource Specialty Pharma, said: “The partnership with Xbrane reflects our shared ambition to drive broader access to cutting-edge biologics worldwide. Xbrane’s proven success in biosimilar development, combined with OneSource’s fully integrated biologics platform, creates a strong platform for global impact. We are pleased to support the scale-up of high-quality biosimilars and advance our vision of being a trusted partner to the world’s leading biotech companies.”

Martin Åmark, CEO 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.”