Fujifilm Kyowa Kirin Biologics announced that its Medical Marketing Application (“MMA”) for FKB327, a biosimilar to AbbVie’s Humira® (adalimumab), has been accepted for review by the European Medicines Agency (“EMA”). Adalimumab is a TNF (tumor necrosis factor) inhibitor that binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Humira® is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis, and ulcerative colitis.
Fujifilm Kiowa Kirin, Samsung Bioepis, and Biogen prevailed in patent litigation involving two patents related to adalimumab in the UK earlier this year, as we reported here. Fujifilm Kiowa Kirin is also developing FKB238, a bevacizumab biosimilar, jointly with AstraZeneca. Bevacizumab is an anti-vascular endothelia growth factor A (Anti-VEGF) specific monoclonal antibody that inhibits formation of new blood vessels and is used to slow the growth of tumors related to several types of cancer. Genentech’s Avastin® (bevacizumab) is indicated for the treatment of conditions related to metastatic colon cancer, lung cancer, glioblastoma, ovarian cancer, and cervical cancer.