Formal Meetings with the FDA Regarding Biosimilars: What’s Changed?
By Zachary Mietus
Recently, biosimilars have made a definite appearance on the FDA’s radar, an expected result after the first biosimilar product gained FDA approval in March and the FDA’s release of four final (“Scientific Considerations in Demonstrating Biosimilarity to a Reference Product,” “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product,” “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,” and “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.”) and one draft guidance regarding biosimilars. The most recent guidance, “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants,” provides the FDA’s perspective on how good meeting management practices (GMMPs) apply to requesting, preparing, scheduling, and conducting biosimilar meetings and gives key differences from drug and biologic product meetings.
Biosimilars will not follow the traditional meeting structure or format. Most sponsors are familiar with Type A, B, and C meetings for drug and biologic products, for biosimilars, this will not be the case. Five types of meetings have been defined as the means to discuss biosimilar product development (BPD):
Biosimilar Initial Advisory meeting:
- Initial assessment to determine if the 351(k) biosimilar pathway is feasible for a certain product
- Preliminary comparative analytical similarity data comparing the potential biosimilar product to the reference product should be included in the meeting package
- A general overview of the development program should also be included
BPD Type 1 meeting:
- Meeting that is comparable to a Type A meeting. It is requested when necessary for a stalled BPD to proceed
- Some reasons to request this meeting are to discuss clinical holds, special protocol assessments, safety issues, and dispute resolution meetings
- Type 1 meetings should be scheduled within 30 days of submitting a meeting request letter
BPD Type 2 meeting:
- Meeting to discuss a specific issue or question that the FDA can provide guidance
- Substantive review of summary data may be required to address the issue
- Type 2 meetings should be scheduled within 75 days of submitting a meeting request letter
BPD Type 3 meeting:
- Meeting to provide in-depth data review and advice regarding a BPD program
- Applies to questions regarding product similarity, study proposals, need for additional studies, and study design
- Type 3 meetings should be scheduled within 120 days of submitting a meeting request letter
BPD Type 4 meeting:
- Meeting to discuss content and format of a 351(k) biosimilar product application
- Type 4 meetings should be scheduled within 60 days of submitting a meeting request letter
FDA has also changed when meeting packages are to be submitted. The content of the meeting package for biosimilar products is very comparable to that of drugs and biologics, however the meeting package for all biosimilar meetings is required to be submitted with the meeting request letter. In contrast, meeting packages for Type B and C meetings for drugs and biologics can be submitted after the meeting request letter, giving the sponsor additional time to create the meeting package. That is not a valid option for sponsors pursuing a biosimilar meeting.
Maximizing the beneficial outcome of an FDA meeting is a critical component of a drug, biologic, or biosimilar product development plan. Providing a meeting request letter and a robust meeting package simultaneously can be a challenge for sponsors with time restrictions or lack of familiarity with the process. The Weinberg Group has extensive experience in preparing FDA meeting request letters and meeting packages and can assist with the creation of meeting documents as well as preparing for FDA meetings. For more information about how we can help you with a critical FDA meeting, please contact us.