OneSource And Xbrane Biopharma Announce Biosimilars Manufacturing Partnership For The Global Markets

OneSource Specialty Pharma Limited, a multi-modality specialty pharma pure-play CDMO, and Xbrane Biopharma AB, a Sweden-headquartered biotechnology company, today announced a 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 U.S. launch.

As part of the agreement, Xbrane will tech transfer its select product(s) to OneSource’s state-ofthe-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 drug substance facility. As part of the collaboration, OneSource has also participated in Xbrane’s latest funding round, reinforcing the long-term 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.”

About OneSource Specialty Pharma Limited
OneSource Specialty Pharma Limited is a pure-play specialty pharmaceutical CDMO. The company focuses on the development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies (soft gelatine capsules). It has five state-of-the-art manufacturing facilities approved by global regulatory authorities and a dedicated team of over 1,200 professionals. OneSource with its development capabilities, industry leading manufacturing capacities, and strong compliance track record, has won trust of global pharmaceutical companies seeking efficient, end-to-end solutions. For more information, visit www.onesourcecdmo.com.

About Xbrane Biopharma
Xbrane Biopharma AB develops biological drugs based on a patented platform technology that provides significantly lower production costs compared to competing systems. Xbrane has a portfolio of biosimilar candidates targeting EUR 23 billion in estimated annual peak sales of the respective reference product. The lead candidate Ximluci is granted market authorization approval in Europe and was launched during 2023. Xbrane’s head office is in Solna, just outside Stockholm. For more information, visit www.xbrane.com