Date: 2018-09-20

Type of information: Granting of a Market Authorisation in the EU

Product name: Hulio®

Compound: biosimilar version of adalimumab Humira®

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Action mechanism:

  • biosimilar/monoclonal antibody/TNF alpha inhibitor. Adalimumab is a monoclonal antibody that binds specifically to TNF alpha and blocks its interaction with  cell surface TNF receptors. It is used to treat many conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis.

Company: Mylan (USA - PA) Fujifilm Kyowa Kirin Biologics (Japan)


  • rheumatoid arthritis
  • ankylosing spondylitis
  • axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
  • psoriatic arthritis
  • psoriasis
  • hidradenitis suppurativa
  • Crohn's disease
  • ulcerative colitis
  • uveitis

Latest news:

  • • On September 20, 2018, Mylan and Fujifilm Kyowa Kirin Biologics announced that the European Commission (EC) has granted marketing authorization for Hulio® (Product Code: FKB327), a biosimilar to AbbVie's Humira® (adalimumab), for all indications. The authorization follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), which concluded that the development program including analytical, functional, clinical and immunogenicity data demonstrated biosimilarity with the reference product, Humira.
  • Mylan plans to launch Hulio® across various markets in Europe on or after Oct. 16. Mylan and Fujifilm Kyowa Kirin Biologics partnered earlier this year. Fujifilm Kyowa Kirin Biologics has a nonexclusive royalty bearing license with AbbVie (Mylan has a sublicense) for the use and sale of Hulio® in European countries. Hulio® is indicated for the same indications of Humira®, including:
  • Adults
  • Rheumatoid arthritis
  • Ankylosing spondylitis
  • Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
  • Psoriatic arthritis
  • Psoriasis
  • Hidradenitis suppurativa
  • Crohn's disease
  • Ulcerative colitis
  • Uveitis
  • Children
  • 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)
  • Uveitis (age 2 and older)
  • • 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:

US authorization:

UE authorization: 2018-09-20

Favourable opinion UE: 2018-07-26

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes