Biogen has signed a license agreement with Xbrane Biopharma to develop, manufacture, and commercialise Xcimzane, a potential biosimilar to Cimzia (certolizumab pegol).

Cimzia is primarily indicated for the treatment of adults with rheumatoid arthritis, along with axial spondylarthrosis, psoriasis and Crohn’s disease. Its sales reached €1.8bn in 2020.

It is a monoclonal antibody specific to tumour necrosis factor alpha (TNF-α), manufactured by Belgian biopharmaceutical firm UCB (Union Chimique Belge).

Under the terms of the agreement, Biogen will obtain exclusive global regulatory, manufacturing, and commercial rights to Xcimzane and hold the marketing authorisation.

Biogen is expected to make an upfront payment of $8m to Xbrane, which is also eligible to receive potential milestone payments of up to $80m, in addition to tiered royalties.

Xbrane will complete the pre-clinical development of Xcimzane and Biogen will undertake all the remaining development activities and costs to achieve marketing authorization.

Biogen global biosimilars head Ian Henshaw said: “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.

“This preclinical biosimilar candidate has the potential to add another option for patients living with Rheumatoid Arthritis and other indications.”

Xbrane Biopharma CEO Martin Åmark said: “Given their vast development and commercialization experience, we are convinced that Biogen is the best possible partner we could have for Xcimzane.”

Xcimzane is a monoclonal antibody therapy, currently in preclinical development.

Established in 1978, Biogen discovers, develops, and delivers advanced therapies for people living with serious neurological diseases, along with other areas.

Xbrane Biopharma is a biotechnology company that develops biosimilars at a lower price after the patent expires for the original drug.

Xbrane has a patented platform technology that provides a lower production cost for biological drugs compared with competing systems.

In addition to Xcimzane, the company’s pipeline includes Xlucane, a biosimilar to Lucentis; Xdivane, a biosimilar to Opdivo; Xtrudane, a biosimilar to Keytruda; and Xdarzane a biosimilar to Darzalex.