FDA Approves Pegfilgrastim Biosimilar, Drafts New Guidance on Formal Meetings Between FDA, Biosimilar Sponsors
Posted 04 June 2018 | By
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 Also on Monday, FDA released new draft guidance on formal meetings between biosimilar sponsors and the agency – replacing previous guidance from November 2015.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Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products: Draft Guidance for Industry