Fujifilm Kyowa Kirin Biologics Announces Successful Adalimumab Biosimilar Trial Results

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On October 19, Fujifilm Kyowa Kirin Biologics (a joint venture between Fujifilm and Kyowa Hakko Kirin), announced successful results in the global Phase 3 study of its Humira® (adalimumab) biosimilar candidate, FKB327.  According to the press release, the study showed that FKB327 and Humira® performed equivalently at improving the disease activity of rheumatoid arthritis after 24 weeks of treatment, as measured by ACR20 response, and no major difference was observed in adverse events between FKB327 and Humira®.

The press release also mentions that the company’s Avastin® (bevacizumab) biosimilar, FKB238, is currently in a global Phase 3 clinical study.  The FKB238 study is being conducted by Centhus Biotherapeutics, a joint venture set up in 2015 between Fujifilm Kyowa Kirin Biologics and AstraZeneca.

Stay tuned to the Big Molecule Watch for further developments.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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