US Pharm. 2016;41(10):10.
Silver Spring, MD—The FDA has approved two biosimilars for the treatment of multiple inflammatory diseases, Erelzi (etanercept-szzs, Sandoz), a biosimilar to Enbrel (etanercept, Amgen), and Amjevita (adalimumab-atto, Amgen), a biosimilar to Humira (adalimumab, AbbVie). Both biological products are approved for the treatment of four types of arthritis (rheumatoid, polyarticular juvenile idiopathic, psoriatic, active ankylosing spondylitis) and plaque psoriasis. In addition, Amjevita is indicated for the treatment of Crohn’s disease and ulcerative colitis. “The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. Erelzi is the third biosimilar approved by the FDA since 2015, and Amjevita is the fourth.
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