AstraZeneca, Fujifilm Form Biosimilars JV
AstraZeneca and Fujifilm Kyowa Kirin Biologics Co. Ltd., a biosimilars company form of Fujifilm, have agreed to establish a joint venture for the development and commercialization of a biosimilar version of bevacizumab, the active ingredient in Roche’s anticancer drug, Avastin. The biosimilar candidate, FKB238, is under development by Fujifilm Kyowa Kirin Biologics Co. Ltd., for treating multiple solid tumors. Avastin was one of Roche’s top-selling drugs in 2014 with sales of CHF 6.4 billion ($6.6 billion).
Under the agreement, the new joint venture will be equally co-funded by the two companies and will use FKB238’s non-clinical, clinical development data compiled by Fujifilm Kyowa Kirin Biologics thus far. Fujifilm Kyowa Kirin Biologics will transfer the rights to FKB238 to the new joint venture and will receive a lump-sum payment of $45 million in return. Fujifilm Kyowa Kirin Biologics commenced its Phase I clinical trial for FKB238 in Europe in November 2014.
In addition, but separate from the newly formed joint venture, Fujifilm Kyowa Kirin Biologics is developing a biosimilar of the anti-TNF-Î± monoclonal antibody, adalimumab, which is in Phase III clinical trials in the United States and elsewhere. Adalimumab is the active ingredient in AbbVie’s Humira, AbbVie’s top-selling drug with 2014 sales of $12.5 billion. Humira is approved for use in moderate to severe rheumatoid arthritis, ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn’s Disease and moderate to severely active ulcerative colitis. Humira is approved in pediatric patients for use in enthesitis-related arthritis, severe plaque psoriasis, severe Crohn’s disease, and active juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy.