On 7 February 2022, US-based Biogen and Sweden-based Xbrane announced an agreement to develop, manufacture and commercialize a proposed biosimilar of certolizumab pegol (Cimzia, UCB). UCB’s patent on Cimzia in the EU expired in 2021 and is set to expire in the US in 2024.

Certolizumab pegol is a monoclonal antibody targeting the inflammatory molecule tumour necrosis factor-alpha (TNF-alpha). It is primarily used to treat rheumatoid arthritis but can also be used to treat other inflammatory conditions including axial spondylarthrosis, psoriasis, and Crohn’s disease.

The proposed biosimilar will be sold under the brand name Xcimzane. Under the terms of the agreement, Xbrane will be responsible for preclinical development of Xcimzane while Biogen will have exclusive global regulatory, manufacturing and commercial rights to the biosimilar and will be Marketing Authorization Holder.

Biogen will make an upfront payment to Xbrane. If development and commercial milestones are achieved, Xbrane will be eligible to receive milestone payments, as well as tiered royalties.

Ian Henshaw, Head of Global Biosimilars at Biogen, said: ‘[…We] are excited to bring this additional asset to our Biosimilars pipeline. This preclinical biosimilar candidate has the potential to add another option for patients living with Rheumatoid Arthritis and other indications’.

Martin Åmark, CEO of Xbrane, added: ‘Given their vast development and commercialization experience, we are convinced that Biogen is the best possible partner we could have for Xcimzane. Today’s announcement confirms Xbrane’s ambition to become a global biosimilar developer’.

In related news, Biogen recently sold its stake in Samsung Bioepis to Samsung Biologics, freeing up capital for acquisitions [1]. However, Biogen will retain commercial rights for Byooviz (ranibizumab-nuna), which was approved in Europe in August 2021 [2], and be able to commercialize the investigational biosimilar candidate SB15 (aflibercept).

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STADA and Xbrane strengthen biosimilars collaboration

References
1. GaBI Online - Generics and Biosimilars Initiative. Samsung to take full control of Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 4]. Available from: www.gabionline.net/pharma-news/samsung-to-take-full-control-of-samsung-bioepis
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of Samsung Bioepis/Biogen’s ranibizumab biosimilar Byooviz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 4]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-samsung-bioepis-biogen-s-ranibizumab-biosimilar-byooviz

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