Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Hulio®
Compound: pegfilgrastim - biosimilar version of Neulasta®
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Company: Mylan (USA - PA)
- rheumatoid arthritis
- ankylosing spondylitis
- axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
- psoriatic arthritis
- hidradenitis suppurativa
- Crohn's disease
- ulcerative colitis
- • On July 26, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive
opinion, recommending the granting of a marketing authorisation for Hulio®,intended for the treatment of certain inflammatory and autoimmune disorders.
Hulio® will be available as a 40-mg solution for injection.
- The decision of the European Commission (EC) on the approval is expected in October 2018.
- 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.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE: 2018-07-26
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: