OneSource Specialty Pharma Limited, a dedicated multi-modality specialty pharma CDMO, and Sweden-based biotechnology firm Xbrane Biopharma AB (listed on Nasdaq under the ticker XBRANE), have announced a strategic partnership for the commercial manufacturing of Xbrane’s biosimilar portfolio for global markets.
Xbrane's biosimilar pipeline targets reference products with an estimated combined annual peak sales potential of EUR 23 billion. Its lead product, Ximluci—a biosimilar of ranibizumab—received market authorization in Europe and was launched in 2023. The product is currently undergoing regulatory review for launch in the United States.
Under this collaboration, Xbrane will transfer manufacturing technology for select products to OneSource’s advanced integrated Drug Substance and Drug Product (DS/DP) facility located in Bangalore, India. The partnership is aimed at enhancing Xbrane’s global supply chain resilience while helping OneSource expedite regulatory approvals, including those from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), for its biologics manufacturing site.
Additionally, OneSource has participated in Xbrane’s latest funding round, reinforcing their long-term strategic alignment.
Neeraj Sharma, Managing Director & CEO of OneSource Specialty Pharma, stated, “This partnership with Xbrane embodies our mutual goal to expand global access to advanced biologics. By combining Xbrane’s proven expertise in biosimilar development with OneSource’s end-to-end biologics capabilities, we are well-positioned to make a meaningful global impact. We are excited to support the scale-up of high-quality biosimilars and further our mission of becoming a trusted partner to leading biotech innovators.”
Martin mark, CEO of Xbrane Biopharma, commented, “Our collaboration with OneSource provides access to world-class, cost-effective manufacturing and deep expertise, which are critical for maintaining our global competitiveness and delivering affordable, high-quality medicines to patients and healthcare systems worldwide.”