Posted 01 April 2013
By Alexander Gaffney, RF News Editor
The US Food and Drug Administration (FDA) has released a fourth and long-anticipated draft guidance document pertaining to the regulatory pathway for biosimilar products, this time on how sponsors should plan to interact with regulators in the context of formal meetings before and during the review of a regulatory application.
The draft guidance, released on 1 April 2013, is only the fourth to be released since the biosimilars pathway was created under the 2010 Patient Protection and Affordable Care Act, otherwise known as Obamacare. The pathway was intended to act as a sort of generic pathway for biological products, which unlike their chemical counterparts cannot be exactly duplicated by competitors.
But since its inception, little has been established in the way of guidance and regulatory pathways by which a company could expect to understand how a biosimilar product would best obtain FDA approval, leaving industry to watch and wait for further instruction.
That isn't to say there's a lack of interest on the part of companies in the biosimilar pathway. In a speech before the Massachusetts Biotechnology Industry Organization, FDA Commissioner Margaret Hamburg said her agency has already received 51 meeting requests for 12 different potential biosimilar products, as well as 15 investigational new drug applications (INDs)-the precursor to clinical testing. No biologics licensing applications (BLAs) have yet been submitted under the 351(k) biosimilars pathway, Hamburg added.
What's so Important About a Meeting, Anyway?
The considerable interest in meeting requests may have in part prompted FDA to release its most recent biosimilar guidance, Formal Meetings between the FDA and Biosimilar Biological Product Sponsors or Applicants. The other contributing factor, FDA explained, is its new authority to collect user fees from industry under the Biosimilar User Fee Act, passed as a part of the FDA Safety and Innovation Act. One of those fees is connected to meetings, for which FDA has agreed to meet certain goals related to timing and completion of those meetings.
Those formal meetings (face-to-face, teleconferences or videoconferences) often involve a sponsor seeking input from FDA on the best way to submit a product, information that needs to be included in a submission, the best design for various clinical research and likely postmarketing requirements. These meetings are often at "critical points in the regulatory and development process," FDA observed, heightening the importance of timely, constructive and efficient meetings so as not to disrupt development or review of a product.
"FDA encourages sponsors and applicants to use the meetings described in this guidance to optimize product development and facilitate submission of marketing applications," the agency explains in the draft guidance.
At its core, the draft guidance is a good meeting management practice (GMMP) document. "The GMMPs in this guidance are intended to provide consistent procedures that will promote well-managed meetings, and ensure that such meetings are scheduled within a reasonable time, conducted efficiently, and documented appropriately," FDA wrote.
Different Types of Meetings
To meet those goals, FDA's draft guidance establishes five different types of meetings to be used at various junctures in the development cycle of a product.
Biosimilar initial advisory meetings are to be used to discuss general matters, most notably including whether the 351(k) biosimilar pathway is appropriate for a given product. Under FDASIA, these meetings should occur within 90 days of FDA receiving a request from a sponsor.
Biosimilar product development (BPD) meetings, meanwhile, are divided into four types, and constitute the remainder of the meeting types. BPD Type 1 meetings are used to discuss clinical hold, set protocol for evaluations under a special protocol assessment, discuss important safety issues or resolve disputes.
Type 2 meetings are meanwhile used to discuss a specific issue to allow FDA to dispense targeted advice; Type 3 are used to review data in depth; and Type 4 are used to discuss the format of a biosimilar application or supplement, as well as its content.
FDA is supposed to hold meetings within 30, 75, 120 and 60 days for BPD Type 1, 2, 3 and 4 meetings, respectively.
Under BsUFA, all BPD meetings are subject to user fees, while the initial advisory meetings are exempt. There are three types of BPD fees: an initial fee, an annual fee and a re-activation fee if a product has since dropped out of the regulatory review process. Fees for the initial BPD meeting must be paid within five days of the meeting request being granted or else the meeting may be cancelled.
The guidance also explains procedures for the content of meeting request submissions, the approval or denial of those submissions, conduct during the meetings and disputes regarding meeting minutes.