How biosimilar labels use the reference product’s data 8

The FDA’s labeling guidance from July 2018 recommends that biosimilar labels contain clinical data from their reference products instead of data collected from biosimilar trials. That means the label of a biosimilar and its reference product could essentially be the same. In general, the guidance contains recommendations. The FDA could require biosimilar-specific data when necessary. 8

In addition:

  • Because the FDA permits biosimilar manufacturers to extrapolate indications, it is likely that the biosimilar label will contain clinical data for indications in which it has not been studied 2
  • The FDA guidance recommends that the "Highlights" section includes the biosimilar’s unique name, date of approval, and disclosure noting that it’s a biosimilar 8
  • Biosimilar names contain an individual, non-meaningful, four-letter suffix in order to distinguish them from their reference product or other biosimilars of the same molecule 7

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