FDA publishes Guideline on Good Meeting Management Practice for Biosimilar Development

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

For pharmaceutical manufacturers, the challenges represented by the development and manufacture of biological generic medicinal products - so called biosimilars - shouldn't be underestimated. Indeed, achieving comparability with the original product - and also providing evidence of it - turns out to be considerably harder and more complex than for common, non-biological preparations.

Early communication with the responsible authorisation and monitoring authorities is meaningful to ensure successful working from the start. Especially for critical steps in the development and authorisation process, scientific and regulatory exchange (also as meetings) with the competent authority representatives is essential.

The Food and Drug Administration (FDA) therefore published a Guideline in November which should serve as a guide for biosimilars manufacturers in the context of formal meetings with the Agency. The "Guidance for Industry Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants" applies thus to all formal meetings, i.e. direct meetings, teleconferences and video conferences. The document supports companies both in creating and submitting a formal meeting request as well as in collecting the respective details and attachments. It contains the principles of the "Good Meeting Management Practices" (GMMPs) and describes standardised procedures for requesting, preparing, planning, performing and documenting such formal meetings.

By means of the Guideline, it should be ensured that appropriate meetings are held within the planned time and are documented effectively and adequately.

Meetings are divided into the following 5 types:

• 1. Biosimilar Initial Advisory meeting - initial meeting to assess whether licensure as a biosimilar is useful and feasible for a particular product.
• 2. BPD Type 1 meeting - meeting to discuss questions which may lead to a development stop, e.g. questions regarding medicinal product safety.
• 3. BPD Type 2 meeting - meeting with regard to questions on study design, ongoing process, or on the first review of data received.
• 4. BPD Type 3 meeting - deals for example with summarised data on similarity intended for the submission, or with full reports for clinical studies.
• 5. BPD Type 4 Meeting - meeting to discuss the format and contents of the final submission.

Please find all the details about the different meeting types and further background information in the "Guidance for Industry Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants".