FDA Approves Cyltezo as Humira Biosimilar

The FDA approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s Humira. 

Cyltezo injection, 40 mg/0.8 mL is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Adult Crohn’s Disease, ulcerative colitis, and plaque psoriasis.

The agency approved Amjevita, Amgen’s Humira biosimilar, in September 2016.