The European Medicines Agency (EMA) accepted to review the Marketing Authorisation Application (MAA) for Fujifilm’s adalimumab biosimilar in May last year. If approved, the product will be launched by drugmaker Mylan in a deal announced today.
“The establishment of this agreement with Mylan attests to the value of Fujifilm Kyowa Kirin Biologics' proprietary technology in biosimilars space and Mylan's significant experience and expertise in regulatory commercialisation,” said Fujifilm Kyowa Kirin Biologics CEO Yoshifumi Torii.
The deal brings another biosimilar to Mylan’s portfolio.
In December 2016, Mylan inked a commercialisation deal with Mabion for the commercial rights to its biosimilar of Roche’s Mabthera (rituximab) in all EU countries and non-EU Balkan states making a combined portfolio of 16 biosimilar and insulin analog generic products.
Adalimumab in Europe
If approved, FKB327 may be one of a number of biosimilar products looking to chip away at adalimumab revenues that last year brought in AbbVie around $4.1bn in Europe alone.
Last week, a settled lawsuit with AbbVie paved the way for Biogen to launch Samsung Bioepis’ Imraldi later this year, but Amgen and Boehringer-Ingelheim both have approved adalimumab products they are looking to launch in the near future.