OneSource Specialty Pharma Partners with Xbrane Biopharma for Commercial Biosimilar Manufacturing
核心洞察
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 Specialty Pharma Limited, a Bangalore-based contract development and manufacturing organization (CDMO) specializing in specialty pharmaceuticals, has announced a strategic partnership with Sweden's Xbrane Biopharma AB (Nasdaq: XBRANE) for the commercial manufacturing of biosimilar products. The collaboration targets Xbrane's portfolio of biosimilar candidates with reference products that collectively represent an estimated EUR 23 billion in annual peak sales.
Lead Biosimilar Shows Market Success
Xbrane's flagship product, Ximluci—a ranibizumab biosimilar—has already demonstrated commercial viability with market authorization approval in Europe and a successful launch in 2023. The biosimilar is currently undergoing the approval process for the United States market, positioning the partnership for potential expansion into the world's largest pharmaceutical market.
Manufacturing and Technology Transfer Agreement
Under the partnership terms, Xbrane will transfer selected products to OneSource's state-of-the-art integrated Drug Substance and Drug Product manufacturing facility located in Bangalore, India. This technology transfer is designed to strengthen Xbrane's global supply chain requirements while providing OneSource with opportunities to pursue regulatory approvals for its biologics manufacturing capabilities from major agencies including the U.S. Food and Drug Administration (搜索) (FDA) and the European Medicines Agency (搜索) (EMA).
Strategic Investment and Long-term Commitment
The partnership extends beyond manufacturing services, with OneSource participating as an investor in Xbrane's recent funding round. This financial commitment reinforces the long-term strategic alignment between the two companies and their shared vision for expanding global access to biologics.
"The partnership with Xbrane reflects our shared ambition to drive broader access to cutting-edge biologics worldwide," said Neeraj Sharma, Managing Director & CEO of OneSource Specialty Pharma. "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."
Global Competitiveness Focus
Martin Åmark, CEO of Xbrane Biopharma, emphasized the partnership's role in maintaining competitive positioning: "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."
The collaboration represents a significant step in the biosimilar manufacturing landscape, combining Xbrane's proven development capabilities with OneSource's integrated biologics platform to address the growing global demand for affordable biologic therapies.