29 August 2017 - Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA, building on 35 years of biologics manufacturing expertise.

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. FDA approved Cyltezo, a biosimilar to Humira, in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases, including:

• moderate to severe active rheumatoid arthritis
  
• moderate to severe polyarticular juvenile idiopathic arthritis**
  
• active psoriatic arthritis
  
• active ankylosing spondylitis (an arthritis that affects the spine)
  
• moderate to severe active adult Crohn’s disease
  
• moderate to severe active ulcerative colitis
  
• moderate to severe plaque psoriasis
  

The European Medicines Agency is expected to provide an opinion on the marketing authorisation application for our biosimilar candidate in 2017.

Read Boehringer Ingelheim press release