On February 7, 2022 Biogen Inc. (Nasdaq: BIIB) and Xbrane Biopharma AB (STO: XBRANE) reported that they have entered into a commercialization and license agreement to develop, manufacture, and commercialize Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA (certolizumab pegol)1 (Press release, Biogen, FEB 7, 2022, View Source [SID1234607852]).
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CIMZIA’s primary indication is for rheumatoid arthritis in adults as well as axial spondylarthrosis, psoriasis and Crohn’s disease. In 2020 global sales of CIMZIA were 1.8 billion Euro2. Under the terms of the agreement, Biogen will gain exclusive global regulatory, manufacturing, and commercial rights to Xcimzane and will be the Marketing Authorization Holder.
"We aim to bring more biosimilars products to more patients and more geographies and we are excited to bring this additional asset to our Biosimilars pipeline," said Ian Henshaw, Head of Global Biosimilars at Biogen. "This preclinical biosimilar candidate has the potential to add another option for patients living with Rheumatoid Arthritis and other indications."
"Given their vast development and commercialization experience, we are convinced that Biogen is the best possible partner we could have for Xcimzane," said Martin Åmark, CEO of Xbrane Biopharma AB. "Today’s announcement confirms Xbrane’s ambition to become a global biosimilar developer."
Under the terms of the agreement, Biogen will make an upfront payment of $8 million to Xbrane. Should certain development and commercial milestones be achieved, Xbrane will be eligible to receive up to $80 million in potential milestone payments. Xbrane is also eligible to receive tiered royalties. Xbrane will be responsible for the completion of pre-clinical development of Xcimzane and Biogen will be responsible for all remaining development activities and costs required to achieve Marketing Authorization in all territories, including those for clinical development.
About Biosimilars
Biosimilars are biologic products that have been demonstrated to be similar in efficacy, safety and immunogenicity to the originator’s approved reference product, with the advantage that they can offer significant cost savings. Biosimilars may lower healthcare system costs broadly, creating headroom for innovation and could enable governments to potentially redirect savings to priorities such as increasing access to transformative therapies.