Mylan's Adalimumab Biosimilar Gains Positive CHMP Opinion

Mylan, together with partner Fujifilm Kyowa Kirin Biologics, has gained a positive opinion on its adalimumab biosimilar, FKB327, from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The committee recommended the biosimilar for all indications of the reference Humira. If the product is granted a marketing authorization by the European Commission, Mylan plans to sell the drug under the brand name Hulio.

Mylan announced its partnership with Fujifilm Kyowa Kirin in April 2018, disclosing that, under its agreement with the developer, Mylan will have the exclusive license to commercialize the biosimilar adalimumab in Europe and will receive an upfront fee from its partner.

In a statement, Mylan’s CEO, Heather Bresch, said of the positive opinion, "We see an urgent need to bring greater access to a more affordable treatment option for patients living with chronic inflammatory conditions such as rheumatoid arthritis [RA], plaque psoriasis and [Crohn] disease. CHMP's decision to recommend the approval of Hulio…represents a positive step to bring this treatment to patients and demonstrates the strength of our collaboration with Fujifilm Kyowa Kirin Biologics."

The companies’ clinical package was supported by data from a phase 3 study of the biosimilar in patients with rheumatoid arthritis. In the double-blind study, patients with active RA that was not adequately controlled with methotrexate were randomized 1:1 to receive 40 mg of either the biosimilar or the reference Humira every other week with concomitant methotrexate.

At week 24, 72.5% of the patients in the biosimilar arm had met American College of Rheumatology criteria for 20% improvement (ACR20), while 74.3% of the reference group had also achieved ACR20. Disease Activity Scores at week 24 and the proportions of patients who achieved ACR50 and ACR70 were also comparable between the 2 treatment arms. Safety profiles and the prevalence of antidrug antibodies (ADA) were also comparable.

In the trial’s open-label extension, patients either continued to receive the biosimilar or the reference adalimumab, 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.

While Mylan says that it expects the European Commission to make its decision on marketing approval for the drug in October 2018, it is unclear when the product could launch in Europe; Mylan announced a settlement with Humira developer AbbVie earlier this month, but the terms of the announced deal apply only to Mylan’s right to market a biosimilar adalimumab in ex-European territories, such as the United States, starting in July 2023. To date, the companies have not announced a settlement that would permit marketing in the European Union.