FDA Issues Draft Guidance On Biosimilar Licensure For Fewer Than All Conditions Licensed for Reference Product

The FDA issued a draft guidance today titled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”  In this guidance, the FDA addresses the following issues:

  • Submission of an application seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all of the reference product’s licensed conditions of use.
  • Development of proposed labeling when the applicant seeks licensure of a proposed biosimilar or proposed interchangeable product for fewer than all of the reference product’s licensed conditions of use.
  • Submission of a supplement to an application for a biosimilar or interchangeable biosimilar to seek licensure for a condition of use previously licensed for the reference product. This may occur, for example, when (1) the biosimilar or interchangeable product was initially licensed for fewer than all of the reference product’s licensed conditions of use, or (2) the reference product is licensed for a new condition of use after licensure of the biosimilar or interchangeable product.
  • Timing for the submission of a 351(k) BLA or supplement to a licensed 351(k) BLA described above with the goal of obtaining licensure of a condition of use for a biosimilar or interchangeable product as soon as possible after the expiration of any relevant exclusivity or patents.

In particular, regarding the timing issue, the draft guidance addresses the situation in which an applicant may want to time licensure to avoid the risk of patent infringement.  For the BLA applicant seeking to time licensure after the expiration of a patent, the draft guidance recommends that the applicant request that FDA refrain from acting on the 351(k) BLA or supplement before a specified date, so long as that date falls on or before the applicable BsUFA goal date.

Comments should be submitted by April 7, 2020 to ensure that the FDA considers the comment.

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