Amgen Moves Closer to Selling Competitor for AbbVie’s Humira
- FDA advisers vote 26-0 for Amgen’s biosimilar to be approved
- Humira is AbbVie’s top-selling drug at $14 billion last year
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Amgen Inc.’s biosimilar version of the arthritis drug Humira cleared a regulatory hurdle, bringing it closer to entering the U.S. market and providing competition that could lower prices for AbbVie Inc.’s best-selling treatment.
A panel of Food and Drug Administration advisers voted 26-0 on Tuesday that the biosimilar, ABP 501, should be approved to treat seven chronic inflammatory conditions for which Amgen is seeking clearance, including rheumatoid arthritis and plaque psoriasis. Humira was AbbVie’s top-selling drug last year at $14 billion, accounting for more than 60 percent of total revenue.