FDA Meeting Types With CDER And CBER For Biosimilar Products

To ensure that regulatory authorities are well-informed and supportive of a planned development trajectory, it is essential that biosimilar developers secure early and successful engagements with the FDA. Not only does this confirm support for the biosimilar products being produced, but it also offers sponsors a valuable opportunity to obtain feedback on crucial development matters, leading to cost reduction, decreased regulatory risks, and faster approval timelines.

To arrange a meeting with the FDA, teams will need to choose their preferred formats, such as face-to-face, teleconference, or written responses, and submit a formal meeting request along with or shortly after an informational package. Following the FDA's review of a meeting request, they will assess whether to grant the meeting and determine the appropriate format.

Get a summary of the different types of meetings under BsUFA for biosimilar products, including their applicability, examples, and the timing parameters of each meeting type.