FDA releases biosimilar meeting guidance

Industry commenters request greater clarification of timelines, data requirements

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SILVER SPRING, Md.—The U.S. Food and Drug Administration(FDA) released a draft guidance in March, "Formal Meetings Between FDA andBiosimilar Biological Product Sponsors or Applicants (11 PLIR 437, 4/5/13)," topropose guidelines for sponsors and applicants in generating and submitting thenecessary documentation to the FDA to arrange meetings regarding theadvancement of biosimilar products. The comment period closed May 31.
The guidance was crafted by the Center for Drug Evaluationand Research in cooperation with the Center for Biologics Evaluation andResearch at the FDA.
The guidance lays out five types of formal meetings that cantake place between applicants and FDA staff: a Biosimilar Initial Advisorymeeting, a BPD Type 1 meeting, BPD Type 2 meeting, BPD Type 3 meeting and BPDType 4 meeting. There are no fees for a Biosimilar Initial Advisory meeting,the guidance notes, though there is a "biosimilar biological productdevelopment fee to participate in the FDA's BPD program to receive a BDP Type1, 2, 3 or 4 meeting for a product," and the BPD fee is an annual per-productfee rather than a per-meeting fee. The draft guidance stipulates that allmeetings require a written meeting request as well as a meeting package, anddepending on the type of meeting, should occur within 30 to 120 calendar daysfrom the date of the request receipt.
Commenters on the draft guidance included several industrymembers, all of whom seemed to share the opinion that adjustments and morespecific details regarding submission requirements and timelines was necessary.
Boehringer Ingelheim Pharmaceuticals Inc. opined that "theprocedures for scheduling biological product development (BPD) meetings shouldnot be substantially different from those by which formal meetings between theFDA and the sponsor for development of other drug products are scheduled,"adding that the currently recommended timelines "are too protracted andcomplicate the agency's advice to sponsors to have a step-wise approach tobiosimilar development." In addition, Boehringer Ingelheim suggested thatmeeting packages should be allowed to be submitted closer to the actualmeeting, calling the simultaneous submission of meeting request and meetingpackage "redundant."
Apotex Inc. pointed out that the draft guidance does notestablish if the listed meetings are meant to be followed in a specific order,or if the Biosimilar Initial Advisory meeting is necessary in every case.
"Whether as a part of this guidance document or pointing toa different document, FDA should consider providing information on the internalprocesses in place at FDA once a meeting is requested. This visibility willprovide the required transparency of the rigorous reviews at FDA and anunderstanding of why it takes FDA such a long time to grant the specificrequested meeting(s) and the preliminary feedback prior to the scheduledmeeting," Apotex noted.
In its comments, the Generic Pharmaceutical Associationrequested clarification of the FDA's requirements for these meetings,specifically in terms of whether a request for a Biosimilar Initial Advisorymeeting can be denied as well as "the timelines within which sponsors couldreceive feedback on information provided within the [biosimilar] package ormeeting follow-up data provided."
Teva Pharmaceutical Industries Ltd. stated that the guidanceshould include information on the FDA's internal process for reviewing meetingbackground packages for biosimilar products, as well as greater clarity as tohow much data the FDA requires to grant an initial advisory meeting and whatkind of data is necessary to ensure a BPD 3 meeting.
The guidance is one of the latest documents on biosimilarsin recent years. The Biologics Price Competition and Innovation Act of 2009amended the Public Health Service (PHS) Act to create an abbreviated licensingpathway in the PHS Act for biological products that demonstrated acceptablebiosimilarity with an FDA-licensed biological product. Following that, theBiosimilar User Fee Act of 2012 adjusted the Federal Food, Drug and CosmeticAct to instate a new user fee program for biosimilar products.

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