FDA Approves Pegfilgrastim Biosimilar, Drafts New Guidance on Formal Meetings Between FDA, Biosimilar Sponsors
The US Food and Drug Administration (FDA) on Monday approved the 11th biosimilar, the first competition for Amgen's Neulasta, and known as Mylan's Fulphila (Pegfilgrastim-jmdb). Also on Monday, FDA released new draft guidance on formal meetings between biosimilar sponsors and the agency – replacing previous guidance from November 2015.The 21-page draft, completed as part of the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 (BPD) meetings – biosimilar initial advisory (BIA), 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.”
The draft also discusses what meeting requests should include and request response timelines. FDA notes there are three formats for meetings: face to face, teleconference/videoconference and written response only.
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products: Draft Guidance for Industry