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

On 5 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 6 April 2020.

This guidance provides recommendations to applicants seeking licensure under the Public Health Service (PHS) Act of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all of the reference product’s licensed conditions of use. Additionally, this guidance also provides recommendations on the submission of a supplement to a licensed 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.

Read more online
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /