FDA approves Boehringer's biosimilar of Humira

Boehringer Ingelheim GmbH (Ingelheim, Germany) said FDA approved Cyltezo, a biosimilar of autoimmune drug Humira adalimumab from AbbVie Inc. (NASDAQ:ABBV). The biosimilar is indicated to treat rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis (UC) and psoriasis.

Cyltezo is the first biosimilar from Boehringer to be approved by FDA and the second Humira biosimilar approved in the U.S. Last year, FDA approved Amjevita adalimumab-atto (ABP 501) from Amgen Inc. (NASDAQ:AMGN) (see BioCentury, Oct. 3, 2016)...