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
