22 May 2017 - Fujifilm Kyowa Kirin Biologics announces that on May 18, 2017, the EMA has accepted for review the marketing authorisation application for FKB327, an adalimumab biosimilar candidate to the fully human anti-TNF-alfa monoclonal antibody, Humira.

In December 2014, Fujifilm Kyowa Kirin Biologics began a Phase 3 global clinical study of FKB327 at sites in the US, Europe and other countries to compare the efficacy and safety profile of FKB327 with Humira (reference product) in patients with moderate to severe rheumatoid arthritis. In this study, FKB327 met the primary endpoint and prespecified criteria for equivalence, and there were no significant differences in the rate of adverse events between FKB327 and Humira. Based on the top-line results, announced on October 19, 2016, Fujifilm Kyowa Kirin Biologics decided to file the MAA for FKB327 to EMA in April 2017.

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