Posted by Michael Wonder on 05 Jun 2018
FDA drafts new guidance on formal meetings between FDA, biosimilar sponsors
4 June 2018 - The US FDA has released new draft guidance on formal meetings between biosimilar sponsors and the agency – replacing previous guidance from November 2015.
The 21-page draft, completed as part of the second iteration of the biosimilar user fee goals, features sections on the four types of biosimilar biological product development meetings – biosimilar initial advisory, Type 1, Type 2, Type 3 and Type 4.
Type 1 meetings include discussions on clinical holds “in which the requester seeks input on how to address the hold issues; or (2) in which a response to hold issues has been submitted, and reviewed by the FDA, but the FDA and the requester agree that the development is stalled and a new path forward should be discussed.”
