Gottlieb's Plan To Boost Biosimilars: Harmonize International Development, Counter 'Misperceptions,' Revamp Reviews

FDA Commissioner Scott Gottlieb said Wednesday (March 7) that the agency is working with HHS Secretary Alex Azar on policies that will help bring more biosimilars to the market, including providing regulatory clarity by integrating policy and review functions; offering tools to help sponsors rely on smaller, targeted trials and develop interchangeable products; countering “misperceptions” about biosimilar safety; and harmonizing development with overseas regulatory partners. Gottlieb, speaking at America's Health Insurance Plans' National Health Policy Conference, also repeatedly said that...