Mylan and Fujifilm Kyowa Kirin Biologics announced that 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.
Mylan CEO Heather Bresch commented, “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. 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.”
Fujifilm Kyowa Kirin Biologics President and CEO Dr. Yoshifumi Torii said, “I am delighted that CHMP decided to recommend approval of our proposed biosimilar adalimumab. We continue to commit all efforts to provide high quality biosimilars and strongly hope that Hulio, the first biosimilar product from Fujifilm Kyowa Kirin Biologics, will provide tremendous value for patients throughout European countries.”
Mylan President Rajiv Malik added, “Mylan is extremely proud to be among the first wave of biosimilars of adalimumab in Europe. We continue to identify opportunities in markets around the world to increase treatment options for patients and minimize the healthcare cost burden often associated with complex products like biosimilars. Today’s milestone demonstrates our commitment to the development and commercialization of biosimilars and complex products globally.”
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
- Hidradenitis suppurativa
- Crohn’s disease
- Ulcerative colitis
CHMP also recommended approval of Hulio for the treatment of pediatric inflammatory diseases, including polyarticular juvenile idiopathic arthritis (age two and older), enthesitis-related arthritis (age six and older), plaque psoriasis (age four and older), Crohn’s disease (age six and older), hidradenitis suppurativa (age 12 and older) and uveitis (age two 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.
(Source: Mylan N.V.)
Filed Under: Drug Discovery