Biogen and Xbrane in deal on rheumatoid arthritis targeting biosimilar

14-Feb-2022 - Last updated on 14-Feb-2022 at 10:05 GMT

Biogen Inc and Xbrane Biopharma AB have entered into a commercialization and licensing agreement on Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA.

In 2020, global sales of CIMZIA (certolizumab pegol) reached €1.8bn (US$2.03m). The UCB blockbuster drug is a tumor necrosis factor (TNF) blocker. Its primary indication is for rheumatoid arthritis in adults as well as axial spondylarthrosis, psoriasis and Crohn’s disease.

First approved in April 2008, CIMZIA’s patent expired last year in the EU while, in the US, itg is set to run its course in 2024.

Under the terms of the agreement, Biogen will gain exclusive global regulatory, manufacturing, and commercial rights to Xcimzane.

Biogen will make an upfront payment of US$8m to Xbrane, while the Swedish company will be eligible to receive up to US$80m in potential milestone payments, should certain development and commercial milestones be achieved; it is also eligible to receive tiered royalties.

Xbrane, whose head office is in Solna, just outside Stockholm, will be responsible for the completion of pre-clinical development of Xcimzane and Biogen is to take on all remaining development activities and costs needed to achieve marketing authorization in all territories, including those for clinical development.

“Given its 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, which has a portfolio of biosimilar candidates targeting €11bn in annual sales of the respective reference products.

Biogen divests stake in biosimilars JV

Last month, Biogen announced it was selling its stake in the biosimilar joint venture, Samsung Bioepis, to partner Samsung Biologics. The South Korean company will buy out the stake in the JV, which was established in 2012, for up to $2.3bn.

Analysts said the deal would give Biogen cash to make acquisitions.

Samsung Bioepis has launched five biosimilars globally: three in autoimmune and two in oncology. Another product is about to be released in the market; and four biosimilars are in Phase 3 trials. Most of its biosimilar sales are in Europe.