FDA aims to juice 'anemic' biosimilars market

FDA Wednesday released a package of policies intended to make development of biosimilar and interchangeable biologic products more efficient, streamline the review of biosimilars and interchangeables, and limit the ability of original biologics manufacturers to delay competition from biosimilars.

In a speech unveiling FDA’s Biosimilars Action Plan, FDA Commissioner Scott Gottlieb characterized the U.S. biosimilars market as “anemic,” noting that of 11 FDA-approved biosimilars only three are marketed. In addition to “patent thickets” and other IP defenses that have kept biosimilars off the market, Gottlieb criticized business practices of biologics manufacturers, PBMs and group purchasing organizations (GPOs) that have limited uptake of products that reach the market. ...