Make The ‘Purple Book’ More Orange, US FDA Told At Biosimilars Hearing
Listing patent and exclusivity information for novel biologics, as is done in the ‘Orange Book’ for small molecules, would help inform biosimilar development, stakeholders say at hearing on facilitating biologic competition and innovation; AbbVie urges FDA to use the Purple Book to clarify the scope of interchangeability decisions.
You may also be interested in...
US FDA asks for comments on whether the policy employed for small molecule generics also should apply to biosimilars.
“We’re not going to wait a decade or more for robust biosimilar competition to emerge,” Commissioner Scott Gottlieb says, noting reference biologic sponsors are repeating some of the delay tactics honed in the small molecule space to keep competition at bay.
Unless reauthorized by Congress, the rare pediatric disease program will begin to expire in September; renewal could bring bigger changes across the three PRV programs, including an FDA-requested clarification of biologic products eligible for vouchers and reforms suggested by sponsors and other stakeholders in a recent GAO report.