If you are part of the Biotechnology industry and have an interest in biosimilar product development and FDA approval you may want to look at a final guidance document on procedures for meetings between biosimilar applicants and the FDA.
Replacing a draft from 2013, the final document, issued November 17th, discusses five types of FDA meetings available to the applicant. The guidance document specifies consistent procedures that promote effective, efficient, reasonably scheduled meetings with appropriate documentation.
In the Biosimilar Initial Advisory meeting, there is a general discussion about the potential for product approval and FDA advice on the expectations of the development program. This meeting does not cover in-depth review of summary data or full study reports; it relates to having sufficient preliminary comparative analytical similarity data which compares at least one lot of the biosimilar product to the U.S. licensed reference product. This allows the FDA to initially determine whether the product has licensing potential and to offer meaningful counsel.
The Biosimilar Biological Product Development Type 1 meeting helps a stalled BPD program to progress. These meetings cover protocol assessments, clinical holds, safety issues and dispute resolutions.
The BPD Type 2 meeting discusses a particular concern such as the design of a proposed study or its endpoints. The meeting may involve extensive review of summary data with the FDA giving targeted advice on a current BPD program.
A comprehensive data review and advice regarding an ongoing BPD program is the agenda of a BPD Type 3 meeting. It includes an in-depth evaluation of full study reports or a comprehensive data package of detailed, compelling analytical similarity data, FDA advice about similarity of the reference product to the proposed biosimilar based a complete data package and advice on the need for further studies that include design and analysis based on a complete data package.
The BPD Type 4 meeting relates to the format and content of product application or supplement submission under section 31(k) of the PHS Act. It does not include extensive review of summary data or full study reports.
The FDA charges a BPD fee for participating in the program and securing a BPD Type 1,2,3,4 meeting. Applicants request meetings depending on the product stage and what kind of advice they need. They can ask for whatever meetings they need to advance their product development. Initially, the FDA will grant applicants one Initial Advisory Meeting and on Type 4 meeting for the biosimilar product
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