BioCentury
ARTICLE | Clinical News

EMA accepts MAA for Humira biosimilar from Fujifilm, Kyowa

June 9, 2017 7:51 PM UTC

Fujifilm Kyowa Kirin Biologics Co. Ltd., a JV between Fujifilm Holdings Corp. (Tokyo:4901) and Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151), said EMA accepted an MAA for FKB327, a biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV) (see BioCentury, April 2, 2012).

In Europe, Humira is approved for autoimmune indications including Crohn’s disease (CD), rheumatoid arthritis (RA), axial spondyloarthritis, psoriatic arthritis, plaque psoriasis, ulcerative colitis (UC) and juvenile idiopathic arthritis...