Biosimilars Naming and Labeling

Most regulatory bodies require specific naming and labeling practices for biosimilars. This is so patients can know what they are taking, doctors will know what they are prescribing and what pharmacists are dispensing, and regulatory bodies can accurately track adverse events and other real-world data.

It’s important to emphasize that naming and labeling requirements vary among regulatory authorities. For example, in the FDA has the following requirements:

U.S. FDA Biosimilar Naming and Labeling Policy1:

  • Identify the original (reference) medicine upon which the biosimilar is based
  • Provide a clear statement as to whether the medicine is
    • Approved as biosimilar by FDA; or
    • Approved as biosimilar and designated as interchangeable with the original (reference) 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


  1. USFDA. Labeling for biosimilar products. July 2018.