www.fdanews.com/articles/183312-fda-approves-cyltezo-as-humira-biosimilar
FDA Approves Cyltezo as Humira Biosimilar
August 31, 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.