Mylan and Fujifilm Kyowa Kirin Biologics announced the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the Marketing Authorization Application of Hulio, the companies' biosimilar to Humira (adalimumab), for all indications.
The decision of the European Commission (EC) on the approval is expected in October 2018, which would grant marketing authorization in the 28 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.
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"We see an urgent need to bring greater access to a more affordable treatment option for patients living with chronic inflammatory conditions such as rheumatoid arthritis, plaque psoriasis and Crohn's disease,” Mylan CEO Heather Bresch said. “CHMP's decision to recommend the approval of Hulio, a biosimilar to adalimumab, represents a positive step to bring this treatment to patients and demonstrates the strength of our collaboration with Fujifilm Kyowa Kirin Biologics."
CHMP has recommended approval of Hulio for multiple chronic inflammatory diseases in adults, including:
- Rheumatoid arthritis
- Ankylosing spondylitis
- Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
- Psoriatic arthritis
- Psoriasis
- Hidradenitis suppurativa
- Crohn's disease
- Ulcerative colitis
- Uveitis
CHMP also recommended approval of Hulio 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 Marketing Authorization Application 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.
Fujifilm Kyowa Kirin Biologics granted an exclusive license to Mylan for commercializing biosimilar adalimumab in Europe.
Adalimumab is an injectable, biologic medication which inhibits Tumour Necrosis Factor (TNF). This 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.