Keywords: biosimilar, interchangeability, adaptive design
Biosimilar development can provide patients with options to benefit from treatments highly similar to currently available therapies, while making costs more manageable. Interchangeability of a biosimilar product refers to a very high standard for similarity to a reference product, whereby the biosimilar may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference. The concept of adaptive designs may face additional challenges in biosimilar development clinical trials compared to other settings. This talk will discuss the overall concept of interchangeability and its regulatory pathways, as well as methodological challenges in utilizing adaptive designs in this area. Some examples will be described.