31 July 2018 - - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization application (MAA) of Hulio, Hertfordshire, England-based global pharmaceutical company Mylan N.V. (NASDAQ, TASE: MYL) and Tokyo, Japan-based biosimilars specialist Fujifilm Kyowa Kirin Biologics Co., Ltd.'s biosimilar to Humira (adalimumab), for all indications, the companies said.
CHMP has recommended approval of Hulio for multiple chronic inflammatory diseases in adults and for the treatment of pediatric inflammatory diseases, including polyarticular juvenile idiopathic arthritis (age 2 and older), enthesitis-related arthritis (age 6 and older), plaque psoriasis (age 4 and older), Crohn's disease (age 6 and older), hidradenitis suppurativa (age 12 and older) and uveitis (age 2 and older).
Data submitted as part of the MAA included similarity assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to the adalimumab reference product, Humira.
The Phase III clinical study, ARABESC, conducted by Fujifilm Kyowa Kirin Biologics, demonstrated no clinically meaningful differences in terms of safety, efficacy and immunogenicity compared with the reference product, Humira, in rheumatoid arthritis patients.
Adalimumab, an injectable, biologic medication, inhibits tumour necrosis factor (TNF) which can cause inflammation in autoimmune diseases such as rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis. By specifically binding to TNF, adalimumab blocks its activity, thereby reducing inflammation and other disease symptoms.
Fujifilm Kyowa Kirin Biologics granted an exclusive license to Mylan for commercializing biosimilar adalimumab in Europe.
Mylan offers a portfolio with more than 7,500 marketed products that include prescription generic and brand-name medicines, and consumer healthcare products.
The company also has healthcare services to help patients access products and adhere to medication regimens. The company markets products in more than 165 countries and territories.
Fujifilm Kyowa Kirin Biologics was established by Fujifilm Corp. and Kyowa Hakko Kirin Co., Ltd. as a company for developing, manufacturing, and marketing biosimilars.
Its pipeline includes an adalimumab biosimilar and a biosimilar of the anti-VEGF humanized monoclonal antibody bevacizumab, a drug used to treat a range of cancers including colorectal and non-small cell lung cancer.
Fujifilm Kyowa Kirin Biologics creates production processes and reduces costs for the production of biosimilars. The company will develop and manufacture reliable, high quality, cost-competitive biosimilar products and commercialize these products in a timely manner.