OneSource Specialty Pharma 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-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 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.