On December 3, 2024, Accord BioPharma, Inc. (“Accord”), the U.S. specialty division of Intas Pharmaceuticals, Ltd. (“Intas”), announced an agreement to acquire Coherus BioSciences, Inc.’s UDENYCA^® (pegfilgrastim-cbqv) business.  UDENYCA^®, the only biosimilar to Amgen’s NEULASTA^® in the United States, is administered the day after chemotherapy treatment to decrease the incidence of infection by febrile neutropenia.  The acquisition “will expand Accord BioPharma’s product portfolio and is expected to position the company for accelerated growth in the biosimilar industry.”

The UNDENYCA^® acquisition follows an announcement last month that Intas and Xbrane Biopharma AB (“Xbrane”) entered into an exclusive global licensing and co-development agreement for Xbrane’s nivolumab biosimilar candidate.  Nivolumab, currently commercialized by Bristol Myers Squibb as OPDIVO^®, is a monoclonal antibody used in cancer immunotherapy. Under the terms of the agreement, Intas will finance and oversee clinical and regulatory development and global commercialization, and Xbrane will receive an upfront payment of 10 million EUR, development milestone payments of 3 million EUR, and, after launch, double-digit royalties on profits.  According to Martin Åmark, CEO of Xbrane, the parties are “very well positioned to bring [their] Nivolumab biosimilar candidate to launch at the time of patent expiration of Opdivo^® in the US in December 2028 and June 2030 in Europe and generate significant profit sharing from that point and onwards. . . . By making these foundational therapies more accessible, biosimilars enable healthcare systems to allocate more resources towards innovative combination treatments, which have the potential to improve over treatment outcomes.”

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