The European Medicines Agency accepted for review a marketing authorization application for the proposed biosimilar, FKB327, in May 2017, and the companies say that they expect to receive the EMA’s decision during the second half of 2018.
Mylan announced today that it has entered into a partnership with Fujifilm Kyowa Kirin Biologics to commercialize an adalimumab biosimilar, referencing Humira, in Europe.
The European Medicines Agency (EMA) accepted for review a marketing authorization application for the proposed biosimilar, FKB327, in May 2017, and the companies say that they expect to receive the EMA’s decision during the second half of 2018. Under the agreement, Mylan will have an exclusive license to commercialize the biosimilar in Europe and will receive an upfront fee from Fujifilm Kyowa Kirin.
In November 2017, at the American College of Rheumatology’s (ACR) 2017 Annual Meeting in San Diego, California, Fujifilm Kyowa Kirin announced results of a double-blind, phase 3 clinical trial comparing the proposed biosimilar to the reference product in 728 patients with rheumatoid arthritis (RA). The trial was followed by a randomized open-label extension study that included a switch between the 2 products.
In the double-blind study, patients with active RA that was not adequately controlled with methotrexate were randomized 1 to 1 to receive 40 mg of either FKB327 or the reference Humira every other week, with concomitant methotrexate. At week 24, 72.5% of the FKB327 group had met ACR criteria for 20% improvement (ACR20), and 74.3% of the reference group had also achieved ACR20. Disease Activity Score (measured in 28 joints with C-reactive protein) at week 24, as well as the proportions of patients who achieved ACR50 and ACR70, was also comparable. Safety profiles, mean serum trough drug concentration at a steady state, and the prevalence of anti-drug antibodies (ADA) were also comparable.
In the open-label extension, patients either continued to receive FKB327 or Humira, or switched from their first treatment to the other. ACR20 response rates were comparable after continuous and switched treatments, and no consistent differences in pharmacokinetics or ADA profiles were observed between continuous or switched treatment groups.
If approved, FKB327 will enter a European biosimilars market that is already heating up for adalimumab; Samsung Bioepis and Biogen announced last week that their approved adalimumab biosimilar, Imraldi, will launch in the European Union on October 16, 2018, the same date that Amgen plans to launch its own approved biosimilar, Amgevita.
Genovese MC, Glover J, Matsunaga N, Chisholm D, Alten R. Efficacy, safety, and immunogenicity in randomized, double-blind and open-label extension studies comparing FKB327, and adalimumab biosimilar, with the adalimumab reference product (Humira) in patients with active rheumatoid arthritis. Presented at the American College of Rheumatology 2017 meeting, November 7, 2017; San Diego, California. Abstract 2799. acrabstracts.org/abstract/efficacy-safety-and-immunogenicity-in-randomized-double-blind-db-and-open-label-extension-ole-studies-comparing-fkb327-an-adalimumab-biosimilar-with-the-adalimumab-reference-product-humira/.