News about GMP/cGMP


FDA: Draft Guidance on Biosimilar Labeling

Following the three final guidances on quality considerations, scientific considerations and Q&As about biosimilars, the FDA has now released a 15-page draft guidance for industry on Labeling for Biosimilar Products. The guidance provides an overview of FDA’s recommendations for biosimilar product labeling and is intended to assist industry in developing draft labeling for submission in proposed biosimilar product applications.


A brief insight:

  • Based on a demonstration of biosimilarity, biosimilar product labeling should include a description of the clinical data that supported safety and efficacy of the reference product as described in the FDA-approved product labeling for the reference product.
  • FDA recommends that biosimilar product labeling incorporate relevant data and information from the reference product labeling, with appropriate product-specific modifications. The relevant data and information from the reference product labeling that should be incorporated into the biosimilar product labeling will depend on whether the applicant is seeking approval for all conditions of use (e. g., indication(s), dosing regimen(s)) or fewer than all conditions of use of the reference product for the biosimilar product.
  • In sections of the biosimilar product labeling that are based on the reference product labeling, it is anticipated that the text will be similar.
  • Text based on the reference product labeling need not be identical and should reflect currently available information necessary for the safe and effective use of the biosimilar product.
  • It should not be implied that the biosimilar product is approved for a reference product indication  or use(s) that have not been approved for the biosimilar product
  • Certain differences between the biosimilar and reference product labeling may be appropriate.
  • A fictional reference product and a fictional biosimilar product are compared in form of illustrative examples in detail.

The document has been issued in draft to provide an opportunity for public comment to industry, health care providers and patients. Comments to the draft guidance are due June 3, 2016. They can be submitted to using Docket Number FDA-2016-D-0643.

The FDA also released a CDER “From Our Perspective” by Leah Christl describing aspects of this draft guidance. The report sums up all current developments relating to biosimilars and is well worth reading.


FDA: News room



No comment has yet been written about this news

Write your comment about this news