FKB 327, an adalimumab biosimilar, is equivalent to Humira its reference drug for treatment of RA.-Fujifilm Kyowa Kirin Biologics Co.Ltd.
Fujifilm Kyowa Kirin Biologics Co., Ltd. announced that it has achieved major objectives in the Phase III global clinical study of FKB 327, an adalimumab biosimilar candidate of the fully human anti-TNF-alpha monoclonal antibody referencing Humira. This Phase III global clinical study of FKB 327 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 FKB 327 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.
Comment: At an earnings call Q3 2015 CEO Rick Gonzales outlined the patent status of Humira. AbbVie claims that Humira patents (14 patents) extend for formulation to 2022 and patents (24 patents) for manufacturing to 2027 and for method of treatment to 2022.
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