Biosimilars Labeling Policies

United States

The FDA issued a final guidance on biosimilars labeling in 2018. The FDA expressed concern that providing data from the studies used to demonstrate biosimilarity could be confusing and irrelevant to the practicing clinician. Instead, the FDA recommends that the label for biosimilars includes a description of clinical data that supports the safety and efficacy of the original biologic medicine highlighting any appropriate product-specific modifications that exist between the biosimilar and the original biologic medicine (eg, differences in administration or storage).1

The label information will also be tailored to only include information on the indications for which the biosimilar has been approved, which may be narrower than the original biologic medicine. Many patient and physician groups, as well as Amgen, believe that the information in a biosimilars label should:2,3

  • Identify the original medicine upon which the biosimilar is based
  • Provide a clear statement as to whether the medicine is
  • approved as biosimilar but NOT designated interchangeable by FDA; or
  • approved as biosimilar and designated as interchangeable with the original biologic medicine
  • Clearly identify the source of the clinical data included on the label
  • Allow for clinical data generated by the biosimilar sponsor to be accessed—through a mechanism such as a “summary of the totality of the evidence” document or directly included in the label

References: 1. US Food and Drug Administration. Guidance for Industry: Labeling for Biosimilar Products. www.fda.gov/downloads/drugs/guidance/compliance/regulatory/information/guidances/ucm493439.pdf. Accessed December 21, 2018. 2. Biosimilars: BIO Comments on FDA Draft Guidance Labeling for Biosimilar Products. www.bio.org/letters-testimony-comments/biosimilars-bio-comments-fda-draft-guidance-labeling-biosimilar-products. Accessed December 21, 2018. 3. Citizen Petition from Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization. www.regulations.gov/document?D=FDA-2015-P-5022-0001. Accessed December 21, 2018.