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Second Humira Biosimilar Approved

— FDA announces approval of Cyltezo

Last Updated August 28, 2017
MedpageToday

Another biosimilar for the best-selling rheumatology drug adalimumab (Humira) was approved by the FDA on Friday, the agency announced.

To be sold as Cyltezo, it is made by Boehringer Ingelheim and will carry the generic name adalimumab-adbm. It's the second adalimumab biosimilar to win FDA approval, following Amjevita, which was OK'd in September 2016.

Cyltezo is approved for most of the same indications as the originator product -- including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis, among others -- and will carry the same cautions and warnings.