The US Food and Drug Administration (FDA) has issued new draft guidance that provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products.
The draft guideline was published in a Federal Register announcement on 5 June 2018. It outlines the type of meetings that biosimilar sponsors can request and the type of meeting formats available.
Formal meetings between the FDA and sponsors or applicants of BsUFA products
Date: June 2018
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm609662.pdf
This new draft guidance replaces the previous guidance for industry entitled ‘Formal meetings between the FDA and biosimilar biological product sponsors or applicants’, which was issued on 18 November 2015, and has been withdrawn.
The guidance discusses the principles of good meeting management practices (GMMPs) and describes standardized procedures for requesting, preparing, scheduling, conducting and documenting such formal meetings. As part of the reauthorization of the Biosimilar User Fee Act (BsUFA), FDA has committed to specific performance goals that include meeting management goals for formal meetings that occur between FDA and requesters.
The draft still includes the same five types of formal meetings that were included in the previous guidance: Biosimilar Initial Advisory (BIA), Biosimilar Biological Product Development (BPD) Type 1, BPD Type 2, BPD Type 3 and BPD Type 4 [1].
One change to the original guidance is the section on BsUFA fees associated with the BPD programme. Under the BsUFA user fee provisions of the FD&C Act, BPD fees are assessed for products in the BPD programme. BPD fees include the initial BPD fee, the annual BPD fee, and the re-activation fee. No fee is associated with a BIA meeting.
In addition, the draft guidance contains information on meeting formats. It outlines three formats for formal meetings:
1. Face to face
Traditional face-to-face meetings are those in which the majority of attendees participate in person at the FDA.
2. Teleconference/Videoconference
Teleconferences/videoconferences are meetings in which the attendees participate from various remote locations via an audio, e.g. telephone, and/or video connection.
3. Written response only (WRO)
WRO responses are sent to requesters in lieu of meetings conducted in one of the other two formats described above. Requesters may request this meeting format for BIA and BPD Type 2 meetings.
FDA has released the draft guidance for a comment period of 90 days, i.e. until 4 September 2018. Comments can be posted to the Dockets Management Staff under Docket No. FDA- 2018-D-1922. This can be done via the website www.regulations.gov or written comments can be mailed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA finalizes guidance for biosimilars meetings [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 29]. Available from: www.gabionline.net/Guidelines/FDA-finalizes-guidance-for-biosimilars-meetings
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Source: Federal Register, US FDA
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