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FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd. (President and CEO: Hideaki Nomura; hereinafter “Fujifilm Kyowa Kirin Biologics”) today announced that it has achieved major objectives in the Phase 3 global clinical study of FKB327, an adalimumab biosimilar candidate of the fully human anti-TNF-α* monoclonal antibody referencing Humira®.
This Phase 3 global clinical study of FKB327 was initiated in December 2014 at sites in the US, Europe, and other countries by Fujifilm Kyowa Kirin Biologics, and compared the efficacy and safety profile of FKB327 with Humira®(reference product) in moderate to severe rheumatoid arthritis** patients.
The primary endpoint (ACR20 response*** ), evaluating the disease activity of rheumatoid arthritis after 24 weeks of treatment, met the prespecified criteria of equivalence. No major difference was observed in adverse events between FKB327 and Humira®.
Fujifilm Kyowa Kirin Biologics was established by FUJIFILM Corporation (President & COO: Kenji Sukeno; hereinafter “Fujifilm”) and Kyowa Hakko Kirin Co., Ltd. (President and CEO: Nobuo Hanai, hereinafter “Kyowa Hakko Kirin”) on March 27, 2012 as a company for developing, manufacturing, and marketing biosimilars. The company has been developing FKB327 and a biosimilar candidate of the anti-VEGF humanized monoclonal antibody “Bevacizumab”(Code No.: FKB238), a drug used to treat a range of cancers including colorectal and non-small cell lung cancer. A Phase 3 global clinical study of FKB238 is being conducted by Centus Biotherapeutics Ltd, a joint venture established by Fujifilm Kyowa Kirin Biologics and AstraZeneca plc (London, UK, CEO: Pascal Soriot) for the development and commercialization of FKB238.
Fujifilm Kyowa Kirin Biologics creates revolutionary production processes and reduces costs for the production of biosimilars by merging the technologies in advanced production, quality control and analysis which Fujifilm has developed over many years through its photographic film business, with the proprietary technologies and know-how which Kyowa Hakko Kirin has accumulated through its biopharmaceutical R&D and manufacturing. Through this partnership, the company will develop and manufacture reliable, high quality, cost-competitive biosimilar products and commercialize these products in a timely manner. With this strategy, Fujifilm Kyowa Kirin Biologics aims to hold a leading position in the expanding biosimilar market.