13 July 2016 - ABP 501 designed to be a lower-cost alternative to AbbVie’s blockbuster Humira.

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 rheumatoid arthritis and other inflammatory diseases.

A panel of FDA advisers voted unanimously in favor of Amgen Inc.’s version of AbbVie Inc.’s Humira, a biotech drug that, according to IMS Health, raked in nearly $15 billion last year. While not binding, the recommendation likely paves the way for FDA approval of the knockoff drug.

For years, biotech drugs faced no competition because there was no regulatory way to approve copycat versions, even after patents had expired. 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.

View Wall Street Journal article