FDA's Draft Guidance on Biosimilar Meetings Needs Revisions, Drugmakers Say

Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.

By Bronwyn Mixter

In comments to the Food and Drug Administration, drug companies said the draft guidance for industry on formal meetings between the agency and biosimilar product sponsors needs some revisions.

FDA released the draft guidance, Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants, in March (11 PLIR 437, 4/5/13). It is intended to assist sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar products. Comments on the draft guidance were due May 31.

The Generic Pharmaceutical Association (GPhA) said in comments that the draft guidance needs clarification to ensure complete understanding of FDA's expectations and requirements. Specifically, GPhA said FDA should “clearly identify the time lines within which sponsors could receive feedback on information provided within the [biosimilar] package or meeting follow-up data provided.”

GPhA also said FDA should clarify whether a request for an initial biosimilar advisory meeting can be denied and, if so, the agency should provide guidance around those circumstances.

Meeting Packages

Teva Pharmaceutical Industries Ltd. said in its comments that the draft guidance should be revised to include information on the internal FDA process for reviewing meeting background packages for biosimilar products in development.

Teva also said the draft guidance should be revised to provide:

• greater details and clarity on the appropriate level of data that is sufficient for briefing documents to meet the FDA's expectations to ensure the initial advisory meeting is granted and that it is granted as an initial advisory meeting versus a biosimilar product development (BPD) type meeting; and

• greater details and clarity on the information and data expectations necessary to support a BPD3 meeting, inclusive of the supporting data needed for the BPD3 meeting request.


According to the draft guidance, there are five types of formal meetings that can occur between sponsors and FDA staff to discuss the development of a biosimiliar product, including:

• an initial advisory meeting to discuss whether licensure may be feasible for a particular product, and, if so, general advice on the expected content of the development program;

• a BPD Type 1 meeting, which is necessary for an otherwise stalled BPD program to proceed;

• a BPD Type 2 meeting to discuss a specific issue or question where the FDA will provide targeted advice regarding an ongoing BPD program;

• a BPD Type 3 meeting, which is an in-depth data review and advice meeting regarding an ongoing BPD program, including substantive review of full study reports and the need for additional studies; and

• a BPD Type 4 meeting to discuss the format and content of a biosimilar product application or supplement.


Boehringer Ingelheim Pharmaceuticals Inc. said in its comments that it “believes that the procedures for scheduling biological product development (BPD) meetings should not be substantially different from those by which formal meetings between the FDA and the sponsor for development of other drug products are scheduled.”

The timelines in the draft guidance “are too protracted and complicate the agency's advice to sponsors to have a step-wise approach to biosimilar development,” Boehringer Ingelheim said.

“Requiring that the meeting request and meeting package be submitted simultaneously makes the meeting request redundant, as very little information can be found in the meeting request that is not also required in the meeting package,” Boehringer Ingelheim said. The company said FDA should allow meeting packages to be submitted closer to the actual date of the meeting.

Sequence of Meetings

Apotex Inc. said that while the draft guidance defines the five types of meetings, it does not clearly state if there is a specific sequence of meetings that a sponsor should follow. For example, it is not clear whether the initial advisory meeting is essential in all cases, the company said.

“Whether as a part of this guidance document or pointing to a different document, FDA should consider providing information on the internal processes in place at FDA once a meeting is requested by” a sponsor, Apotex said. “This visibility will provide the required transparency of the rigorous reviews at FDA and an understanding of why it takes FDA such a long time to grant the specific requested meeting(s) and the preliminary feedback prior to the scheduled meeting.”

Apotex also said it has concerns about the extensive amount of information that FDA has requested to be included in the biosimilar package for the abbreviated pathway. While the pathway is intended to be abbreviated, it “will actually be anything but that,” the company said.

Teva is based in Israel, Boehringer Ingelheim is based in Germany, and Apotex is based in Canada.

The draft guidance is at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM345649.pdf.

Request Health Care on Bloomberg Law