A biosimilar product is a biologic product that is accepted based on representing that it is highly similar to an FDA approved biologic product, known as a reference product, and has no clinically meaning variations in terms of safety and effectiveness from the reference product.

  • Track 1-1 SBP (Similar biologic Product)
  • Track 2-2 FOB (Follow-On Biologic)
  • Track 3-3 SEB (Subsequent Entry Biologic)

Related Conference of Pharmaceutical Sciences