FDA Finalizes Guidance on Formal Meetings with Biosimilar Sponsors

Regulatory NewsRegulatory News | 17 November 2015 |  By 

The US Food and Drug Administration (FDA) on Wednesday plans to release finalized guidance on formal meetings between FDA and biosimilar sponsors.

The agency said that as a result of the public comments on the draft guidance from April 2013, information has been added “to provide clarity on the process for requesting meetings, including identifying the appropriate meeting type and the data expectations to support the appropriate meeting type.”

The Generic Pharmaceutical Association (GPhA) previously called for FDA to specify which electronic Common Technical Document (eCTD) submission format it would accept and what needed to be included on the eCTD.  

Formal Meetings

The guidance addresses five types of meetings between the agency and biosimilar sponsors: (1) Biosimilar Initial Advisory meeting; (2) Biosimilar Product Development (BPD) Type 1 meeting; (3) BPD Type 2 meeting; (4) BPD Type 3 meeting; and (5) BPD Type 4 meeting.

“The good meeting management practices in this guidance are intended to provide consistent procedures that will promote well-managed meetings and to ensure that such meetings are scheduled within a reasonable time, conducted efficiently, and documented appropriately,” FDA said.

FDA is supposed to hold meetings within 30, 75, 120 and 60 days for BPD Type 1, 2, 3 and 4 requests, respectively.

All BPD meetings are subject to user fees, while the initial advisory meetings are exempt. There are three types of BPD fees: an initial fee, an annual fee and a reactivation fee if a product has since dropped out of the regulatory review process. Fees for the initial BPD meeting must be paid within five days of the meeting request being granted or else the meeting may be canceled.

The guidance also explains procedures for the content of meeting request submissions, the approval or denial of those submissions, conduct during the meetings and disputes regarding meeting minutes.

Federal Register


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy