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News|Articles|February 6, 2020
Guidance on Biosimilar Licensure
Author(s)Pharmaceutical Technology Editors
FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.
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On Feb. 6, 2020, FDA published
The guidance provides recommendations for applicants seeking licensure under section 351(k) of the Public Health Service (PHS) Act. It also provides recommendations on the submission of a supplement to a licensed 351(k) biologics license application (BLA) for those 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. Additionally, the guidance discusses the development of proposed labeling and timing for the submission of a 351(k) BLA or supplement to a licensed 351(k) BLA.
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