FDA May Push Back Release of Biosimilar Interchangeability Draft Guidance

Posted 22 September 2016 By Zachary Brennan


Although the Food and Drug Administration (FDA) has continued to say publicly that draft guidance on how an interchangeable biosimilar will be defined should come out by the end of 2016, the user fee reauthorization commitment letter released this week says the draft will publish sometime before 31 December 2017.

The letter, which contains the performance goals and procedures for the Biosimilar Biological Product User Fee Act (BsUFA) reauthorization for fiscal years 2018-2022 (known as BsUFA II), also said that FDA will work toward the goal of publishing a revised draft or final guidance on interchangeability within two years after the close of the public comment period of the draft, meaning the final interchangeability guidance may not take effect before 2019.

FDA also sets the same 31 December 2017 deadline for draft guidance describing statistical considerations for the analysis of analytic similarity data intended to support a demonstration of “highly similar” for biosimilars, and says it will work toward the goal of publishing a revised draft or final guidance within 18 months after the close of that public comment period.

Other Guidance

In terms of other guidance for biosimilar developers, the agency noted that on or before 31 March 2019, FDA will publish draft guidance describing processes and further considerations related to post-approval manufacturing changes for biosimilars.

FDA will also publish revised draft guidance on “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants” no later than 30 September 2018, and it will update the current draft or final guidance on “Best Practices for Communication Between IND Sponsors and FDA During Drug Development,” to apply to communications between IND sponsors and FDA during biosimilar development by 31 December 2018.

In addition, FDA will work towards the goal of publishing revised draft guidance or final guidance documents on or before 31 May 2019 for draft guidance published between 2014 and 30 September, including:


As far as biosimilar review performance goals under the next BsUFA, for original 351(k) biologics license application (BLA) submissions, the BsUFA review clock will begin at the conclusion of the 60 calendar day filing review period that begins on the date of FDA receipt of the original submission. FDA plans to review and act on 90% of original 351(k) BLA submissions within 10 months of the 60-day filing date.

In terms of Biosimilar Biological Product Development (BPD) meeting requests, FDA will notify the requester in writing of the date, time and place for the meeting, as well as expected Center participants following receipt of a formal meeting request and background package.

FDA says it will respond to meeting requests and provide notification within 21 calendar days for initial advisory meetings, 14 calendar days for BPD Type 1 meetings and 21 calendar days for Type 2-4 meetings.

For Biosimilar Initial Advisory and BPD Type 2 meetings, FDA says the sponsor may request a written response rather than a face-to-face meeting, videoconference or teleconference, and if deemed appropriate, FDA will notify the requester of the date it intends to send the written response.

In terms of meeting scheduling or written responses, Biosimilar Initial Advisory requests will be responded to in 75 calendar days from receipt of meeting request and background package and for BPD 2 meetings it will be 90 calendar days.

And in terms of scheduling a time for a meeting, for BPD 1 meetings, FDA will offer a response in 30 calendar days from receipt of meeting request and background package, a response to BPD 3 requests in 120 calendar days and within 60 calendar days from receipt of meeting request and background package of BPD 4 requests.


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Categories: Biologics and biotechnology, Clinical, Government affairs, Postmarket surveillance, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA

Tags: biosimilar, interchangeability, BsUFA

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