Pharmaceutical company Mylan NV (NASDAQ:MYL) and Fujifilm Kyowa Kirin Biologics Co Ltd reported on Friday that the partnership expects Marketing Authorisation Application for Hulio in October 2018, in the 28 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.

The companies said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the Marketing Authorisation Application of Hulio,which is the biosimilar to Humira (adalimumab) for multiple chronic inflammatory diseases in adults.

CHMP has recommended approval of Hulio for rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis.

Additionally, the CHMP recommended approval of Hulio for the treatment of paediatric inflammatory diseases: 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).

Adalimumab is an injectable, biologic medication which inhibits Tumour Necrosis Factor (TNF). By specifically binding to TNF, adalimumab blocks its activity, thereby reducing inflammation and other disease symptoms, according to the companies.

This Marketing Authorisation Application included data from the similarity assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to the adalimumab reference product, Humira. Fujifilm Kyowa granted an exclusive license to Mylan for commercialising biosimilar adalimumab in Europe.