FDA Biosimilars Labeling Guidance

Recently, the FDA released industry guidance regarding biosimilar product labeling, which is entitled “Labeling for Biosimilar Products” (“Biosimilars Labeling Guidance”).  The Biosimilars Labeling Guidance provides recommendations for biosimilar product labeling, specifically for the proposed package insert, and is intended to help applicants in drafting labels for an aBLA.

Some highlights from FDA’s Biosimilars Labeling Guidance include:

  • Studies conducted to support biosimilarity generally should not be included in biosimilar product labeling. Biosimilar product labeling should incorporate relevant data and information from the reference product labeling, including clinical data that supported FDA’s finding of safety and effectiveness of the reference product.
  • In sections of the biosimilar product labeling that are based on the reference product labeling, the text does not need to be identical to the reference product labeling but should likely be similar.  It should, however, reflect any difference between the biosimilar product and the reference product that is necessary to inform safe and effective use of the biosimilar product.
  • Explanations of when to use the biosimilar product proper name, the biosimilar product proprietary name, the reference product name, and the core name.
  • FDA recommends including a statement, placed on the line immediately beneath the initial U.S. approval in the Highlights section, that the product is biosimilar to the reference product. It should read as follows: [BIOSIMILAR PRODUCT’S PROPRIETARY NAME (biosimilar product’s proper name)] is biosimilar to [REFERENCE PRODUCT’S PROPRIETARY NAME (reference product’s proper name)].

FDA’s Biosimilars Labeling Guidance also provides instructions on how to submit initial and revised labeling, and makes clear that any specific recommendations for labeling for interchangeable products, including any interchangeability statement similar to the biosimilarity statement described in the Guidance, will be provided in future guidance.