Fourth FDA Guidance: Formal meetings between the FDA and Biosimilar product sponsors or applicants

April 2, 2013 9:37 AM


The States’ are working on developing regulations for the upcoming biosimilars boom and at the same time, FDA is still working on issuing guidances for the industry.

Latest biosimilar guidance, “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants” was issued last week and is open for comments from the stakeholders.

This guidance provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and biosimilar biological product sponsors or applicants. The Biosimilar User Fee Act of 2012 (BsUFA), enacted as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize a new user fee program for biosimilar biological products.

The FDA has committed to meeting certain performance goals set forth in a letter from the Secretary of  Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives. The performance goals include meeting management goals for formal meetings that occur between the FDA and sponsors or applicants during the development phase of a biosimilar biological product.

The guidance give detailed information of meeting types: There are five types of formal meetings that can occur between sponsors or applicants and FDA staff to discuss development of a biosimilar biological product:

1. Biosimilar Initial Advisory meeting
2. BPD Type 1 meeting: A BPD Type 1 meeting is a meeting that is necessary for an otherwise stalled BPD program to proceed.
3. BPD Type 2 meeting: A BPD Type 2 meeting is a meeting to discuss a specific issue (e.g., proposed study design or endpoints) or questions where the FDA will provide targeted advice regarding an ongoing BPD program.
4.BPD Type 3 meeting: A BPD Type 3 meeting is an in-depth data review and advice meeting regarding an ongoing BPD program.
5. BPD Type 4 meeting: A BPD Type 4 meeting is a meeting to discuss the format and content of a biosimilar biological product application or supplement to be submitted under section 351(k) of the PHS Act.

More information about the meeting types, requesting a meeting, scheduling meetings, package contents, submission and about all procedures can be found in the draft guideline.


Source: FDA,


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