FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Approves Cyltezo as Humira Biosimilar

Sept. 1, 2017

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.

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