26/27 November 2019
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:
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".