The second-biggest selling drug in the world could get some cheaper competition in the U.S., after a federal panel endorsed an alternative version of the pricey medication used to treat some inflammatory diseases.
A panel of Food and Drug Administration advisers voted unanimously in favor of Amgen's version of AbbVie's Humira, a biotech drug that raked in nearly $15 billion last year. While not binding, the recommendation paves the way for FDA approval of the knockoff drug.
For years, biotech drugs faced little competition because there was no regulatory way to approve copycat versions, even after patents had expired. But if approved, Amgen's drug would join a new wave of so-called biosimilars, which have the potential to generate billions in savings for U.S. insurers, doctors and patients.