On June 5, 2018, the FDA released new draft guidance for the biosimilar industry. The draft guidance provides recommendations regarding the timing, scope and conduct of formal meetings between the FDA and applicants relating to the development and review of biosimilar or interchangeable biological products. Along with this notice, the FDA formally withdrew the previous guidance for industry that was released November 18, 2015. Although the new guidance provides details on the “nuts and bolts” of meetings with the FDA, it does not provide greater insight into the substantive requirements for biosimilar or interchangeable approval.
The guidance generally “discusses the principles of good meeting management practices” and “describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings.” Id. at 2. The guidance describes the five types of formal meetings that occur between FDA staff and biosimilar or interchangeable applicants: Biosimilar Initial Advisory (BIA), Biosimilar Biological Product Development (BPD) Type I, BPD Type 2, BPD Type 3 and BPD Type 4 meetings. Id. at 2.
The BIA Meeting is “an initial assessment” meeting “limited to a general discussion regarding whether licensure under section 351(k) of the Public Health Service Act may be feasible for a particular product, and if so, general advice on the expected content of the development program.” Id. at 3. For this type of meeting, the applicant should include in the meeting packet “preliminary comparative analytical similarity data from at least one lot of the proposed biosimilar or interchangeable product compared to the U.S.-licensed referenced product.” Id. No fee is associated with a BIA meeting.
BPD Type 1 meetings should be requested to proceed with stalled development programs or to address important safety issues. Id. at 3. BPD Type 2 meetings are requested to discuss specific issues in an ongoing development program and may include substantive review of summary data, but not review of full study reports. BPD Type 3 meetings are in-depth data review and advice meetings based on comprehensive data packages and may involve discussions regarding the need for additional studies. BPD Type 4 meetings are pre-submission meetings to discuss the format and content of a complete application for an original biosimilar or interchangeable product application or supplement. Id. at 5. The guidance indicates the meetings need not be requested in any particular order—rather, the request depends on the stage of the development program and/or the advice sought. Id. at 3.
Of particular interest is the fact that the guidance provides proposed timelines for the FDA to respond to meeting requests. The guidance indicates a response will be given in 14 to 21 days, depending on meeting type, and the meetings will be scheduled 30 to 120 calendar days from receipt of the meeting request. Id. at 9-10. Meeting requests may be denied if they are, for example, “premature for the stage of product development, [are] clearly unnecessary, or [are] not appropriate for the format requested (e.g., face to face/video conference/teleconference versus WRO) or the meeting package does not provide an adequate basis for the meeting discussion.” Id. at 8. The guidance indicates that meetings can be canceled if, for example, fees are not timely paid. Id. at 14.
The guidance also states that the FDA meeting minutes are the official records of the meetings, and provides a mechanism for correcting any alleged discrepancies in the minutes. Id. at 15-16.
The draft guidance reflects efforts by the FDA to continue development of the biosimilar market in the U.S. by refining the process for FDA approval. Although the FDA has provided this and other guidance (see, e.g., substantive draft guidance on interchangeability here, released in January 2017), only eleven biosimilars have been approved to date. Notably, no interchangeables have been approved, even though at least 14 interchangeable applications have been submitted to the FDA. It is unclear whether this particular draft guidance, which focuses on the scope, format, and content of meetings with the FDA regarding biosimilar and interchangeable applications—as opposed to, for example, substantively addressing standards for demonstrating a product is interchangeable—will facilitate the approval of the first interchangeable in the U.S.
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.
Jenny Shmuel, Ph.D., represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and has examined and cross-examined witnesses at trial.
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