This week’s announcement of a public meeting to discuss a user fee structure for biosimilars marks another step towards implementation of the Biologics Price Competition and Innovation Act of 2009, which mandates that FDA establish an approval pathway for biosimilars. The question on everyone’s mind regarding the definition of a biosimilar has yet to be answered, but the fee announcement and the accompanying proposed review of performance goals and procedures provides some welcome information about what the approval process will look like.
The draft performance goals outline timelines for review of applications, timelines for review of proprietary names, and procedures for resolving disputes. There is a section detailing the procedure a sponsor should follow to get specific questions answered about protocol design, or about scientific or regulatory questions pertaining to their submission, and a timeline for the agency’s response. In addition, there is an explanation of the types of meetings the sponsor should schedule with FDA, the information required by FDA before scheduling the meeting, and the timeline or conditions during the submission process that would require scheduling each type of meeting.
The detailed definition of each meeting type in the draft reminds us that FDA does not envision a “one size fits all” approach to biosimilars approvals. There’s a meeting for every contingency, and it appears that they anticipate a high degree of interaction between sponsors and government to shepherd molecules through the approval process.
See related articles: