Guidance on Biosimilar Licensure

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FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.

On Feb. 6, 2020, FDA published draft guidance in a series of guidance documents developed to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The new draft guidance discusses licensure of biosimilars and interchangeable biosimilars for fewer than all conditions of use than the reference product. 

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.


Source: FDA