Adalimumab Biosimilar Demonstrates Non-Inferiority For Efficacy and Safety

Biosimilar News

At the EULAR Annual Congress this week, Rieke H.E. Alten, MD, working at the University of Berlin, presented data from a randomized, double-blind, Phase III study comparing adalimumab and FKB327, Fujifilm Kyowa Kirin Biologics’ proposed biosimilar, in 730 patients with active rheumatoid arthritis (RA) inadequately controlled on methotrexate. The study concluded that safety profiles, antidrug antibody formation and pharmacokinetics were similar “supporting the comparability of FKB327 and [adalimumab] in patients with active RA.”

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