FDA approve Cyltezo (adalimumab biosimilar) for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis.-Boehringer.

Boehringer Ingelheim announced that the FDA approved Cyltezo (adalimumab biosimilar), 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, moderate to severe active adult Crohn's disease, moderate to severe active ulcerative colitis and moderate to severe plaque psoriasis.

The FDA approval is based on a comprehensive data package comprised of analytical, pharmacological, non-clinical and clinical development studies demonstrating that Cyltezo is biosimilar to Humira. The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. The European Medicines Agency is expected to provide an opinion on the marketing authorization application for our biosimilar candidate in 2017.