Amgevita, Solymbic regulatory update

The European Commission approved ABP 501 from Amgen to treat autoimmune diseases under 2 names: Amgevita and Solymbic. The biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV, Chicago, Ill.) is approved to treat rheumatoid arthritis (RA), ankylosing spondylitis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease (CD), ulcerative colitis (UC), uveitis, polyarticular juvenile idiopathic arthritis (JIA) and enthesitis-related arthritis. The company said it is still evaluating its launch plans in the EU and declined to discuss its price. The company pursued the duplicate application strategy as it considered "a multitude of commercial options that may be present" at launch (see BioCentury, Feb. 2)...