FDA: Amgen’s Biosimilar “Highly Similar” to Abbvie’s Humira

U.S. FDA News

A preliminary review by FDA staff found that Amgen Inc.’s biosimilar of AbbVie Inc.’s Humira® showed potency and safety similar to the original product. Humira® (adalimumab) is the top-selling drug in the world and is used to treat autoimmune conditions including rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. A panel will meet on Tuesday to determine whether to recommend approval of Amgen’s biosimilar product, ABP 501.

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