Silver Spring, MD—The FDA’s Arthritis Advisory Committee has recommended a biosimilar version of AbbVie’s adalimumab (Humira). The FDA panel voted unanimously in favor of licensing ABP 501, the biosimilar of Humira from Amgen. The blockbuster biologic Humira is approved for the treatment of several automimmune diseases, including rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis. To date, the FDA has approved two biosimilars (Zarxio and Inflectra), with several others, including one for etanercept (Enbrel), pending review. The savings realized by putting patients on far less costly biosimilars are estimated to be billions of dollars annually. The FDA does not necessarily have to follow the panel’s recommendation, and a final decision on the approval of the agent will be made by September.
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