The product label should contain all the information to enable a physician to make an informed treatment choice, including:

  • That the product is a biosimilar
  • Name of the biosimilar’s reference product
  • Analytical and clinical data used to demonstrate biosimilarity
  • Indications for which the biosimilar is approved, including whether or not these were studied
  • Indications for which the originator is approved, but the biosimilar is not
  • Whether the biosimilar is interchangeable with the originator product. (This means the FDA has decided the biosimilar can be safely switched back and forth with the originator product)
  • Post marketing surveillance data