FDA Issues Draft Guidance for Industry on Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed

The Food and Drug Administration (FDA) published a draft guidance for industry entitled, “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed .” The guidance provides recommendations to applicants seeking licensure under section 351(k) of the Public Health Service Act of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all of the reference product’s licensed conditions of use.

 

The guidance also provides recommendations on the submission of a supplement to a licensed 351(k) biologics license application (BLA) seeking to add a condition of use that previously has been licensed for the reference product to the labeling of a licensed biosimilar or interchangeable product, including considerations related to the timing of such submissions.

 

The guidance also outlines new targeted timelines for review of supplements to licensed biosimilar or interchangeable 351(k) BLAs seeking licensure for additional conditions of use for which the reference product has been licensed.

 

For information on how to submit comments related to this draft guidance, please see the Federal Register Notice.

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