Insider: WH Has Competition Concerns With FDA Biosimilar Naming Plans

July 1, 2015 at 2:59 PM
Two industry insiders told Inside Health Policy that the hold up of the biological naming guidance is beyond FDA, with one insider saying that the hold up is due in part to the belief by some within the White House and HHS that the naming issue has more to do with competition than safety. They both additionally said that internationally, FDA is being looked to as a leader in this area, including by the World Health Organization, with one...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.