FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics license applications (BLAs) for biosimilar and interchangeable products, and for other parties interested in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This new guidance aims to further facilitate the development of proposed biosimilar products and proposed interchangeable products.

The BPCI Act created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. This newly released draft guidance is the third FDA question-and-answer guidance on the BPCI Act, with the previous two released in December 2018: Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry and New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).

With the new guidance, FDA added four more questions and answers for a total of 28 when combining past guidance documents. Below are summaries of the new Q&As:

Q25. How will FDA review applications for licensure as an interchangeable biosimilar where data supports biosimilarity but NOT interchangeability?

A. Applicants seeking licensure for an interchangeable biosimilar should affirmatively state that fact in their submission cover letter. Otherwise FDA will only review the application under the standards of a biosimilar product. When an applicant indicates a desire for interchangeability licensure, FDA will review as both an interchangeable biosimilar and also as a biosimilar. FDA will split the application and take separate actions on the product if it determines the application only supports licensing the product as a biosimilar and not an interchangeable. For example, FDA could approve the product as a biosimilar, but issue a complete response letter regarding interchangeability allowing the applicant the opportunity to supplement the interchangeable biosimilar submission. If an applicant only desires to seek interchangeability licensure, the cover letter should include “INTERCHANGEABLE-ONLY REVIEW” and FDA will only review the product as an interchangeable.

Q26. How should a BLA holder proceed if they want to seek licensure of their biologic as biosimilar/interchangeable with another BLA reference product?

A. BLA holders should proceed in similar fashion to any other applicant seeking licensure as a biosimilar/interchangeable. Specifically, BLA holders should submit an original application for licensure as a biosimilar and/or interchangeable product. It is not necessary to revoke the BLA in order to obtain designation as a biosimilar/interchangeable product.

Q27. Does FDA have any recommendations for labeling interchangeable biosimilars?

A. FDA defers to its prior guidance (Biosimilar Labeling Guidance) for interchangeable biosimilar products noting the labeling should include relevant data and information from the reference product supporting the safety and effectiveness of the reference product. The labeling should not include data supporting the interchangeability of the product. However, the FDA notes the recommendations described in sections IV through VII of the Biosimilar Labeling Guidance generally do apply to interchangeable products and will provide additional guidance as it gains experience with interchangeable biosimilars.

Q28. Does FDA recommend that labeling for an interchangeable product include a statement on interchangeability?

A. Yes. FDA recommends including a statement immediately beneath the Highlights of Prescribing Information that the product is interchangeable with the reference product. Interchangeable products should also have a footnote explaining the definition of an “interchangeable product.” FDA provides recommended language in the guidance.

This new draft guidance is open for public comment until January 19, 2021.