Biogen, Xbrane Enter Commercialization Agreement for Cimzia Biosimilar

Biogen and Xbrane Biopharma have entered into a commercialization and license agreement for a biosimilar candidate referencing Cimzia (UCB; certolizumab pegol), Xcimzane, for the treatment of rheumatologic conditions.

Xcimzane is a monoclonal antibody in preclinical development phases. The reference product’s primary indication is for rheumatoid arthritis, but it is also authorized for use in treating axial spondylarthrosis, psoriasis, and Crohn disease. In 2020, Cimzia achieved global sales of €1.8 billion ($2.0 billion).

“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,” said Ian Henshaw, head of global biosimilars at Biogen, in a statement.

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

Terms of the Agreement

Under the agreement, Biogen will be responsible for exclusive global regulatory application and approvals. The Cambridge, Massachusetts–based company will also have the manufacturing and commercial rights to Xcimzane and be considered the marketing authorization holder.

Biogen will make an $8 million up-front payment to Solna, Sweden–based Xbrane. As certain development and commercial milestones are achieved, Xbrane will be eligible to receive up to $80 million in milestone payments. Xbrane will also be responsible for the preclinical development of the drug and Biogen will be in charge of all remaining development activities.

Biogen will also be accountable for any costs associated with clinical development and obtainment of marketing authorization in all territories.

Other Biogen and Xbrane Biosimilars

Biogen has 3 other biosimilars, all of which are approved in the European Union: Benepali (etanercept), Flixabi (infliximab), and Imraldi (adalimumab). Benepali references Enbrel and was the first etanercept biosimilar approved in Europe. Flixabi references Remicade, and Imraldi references Humira. None of these have been approved by the FDA.

Biogen also has a commercialization agreement with Samsung Bioepis for Byooviz, a ranibizumab biosimilar referencing Lucentis for the treatment of neovascular age-related macular degeneration, diabetic macular oedema, and other ophthalmic conditions. Byooviz has been approved in both the United States and the European Union.

The news of the agreement with Xbrane comes shortly after Biogen announced selling its 50% ownership stake in fellow biosimilar development company, Samsung Bioepis. Biogen is expected to gain $2.3 billion for the sale.

In addition to Xcimzane, Xbrane is also working on Xlucane, a biosimilar for Lucentis; Xdivane, a biosimilar for Opdivo (nivolumab); Xtrudane, referencing Keytruda (pembrolizumab); and Xdarzane, a biosimilar for Darzalex (daratumumab). Xlucane is the only biosimilar in the registration phase, but it has not been approved.

Reference

Biogen and Xbrane announce commercialization and license agreement for proposed biosimilar referencing CIMZIA (certolizumab pegol) with the potential to treat rheumatoid arthritis. News release. The American Society of Nephrology; February 7, 2022. investors.biogen.com/news-releases/news-release-details/biogen-and-xbrane-announce-commercialization-and-license. Accessed February 9, 2022.