27 July 2018 - Mylan and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the EMA's CHMP has adopted a positive opinion for the marketing authorisation application of Hulio, the companies' biosimilar to Humira (adalimumab), for all indications.

The decision of the European Commission on the approval is expected in October 2018, which would grant marketing authorisation in the 28 European Union member countries and European Economic Area member states of Norway, Iceland and Liechtenstein.

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
• Crohn's disease
  
• Ulcerative colitis
  
• Uveitis
  

Read Mylan press release