12^th Asian Biologics and Biosimilars Congress

In the USA only interchangeable products can be substituted for the reference product by a pharmacist without the intervention

of a health care provider. The interchangeability regulation is in the form of guidance: Interchangeable biologics must be biosimilar to the reference biologic.If administered more than once, data must show the safety and efficacy risks of switching. If not administered more than once, justify the omission of a switching study. The clinical data must demonstrate switching risk in all of the reference biologic’s licensed conditions of use.The data must support the “totality of the evidence” and “reduction of residual uncertainty”. Switching study design is de ned and described in the guidance. Guidance describes what is insuffiecient to demonstrate interchangeability. The use of post-marketing data from a biosimilar. The presentation and design attributes must be the same to enable substitution. The impact of biosimilar interchangeability in the USA will be more than positive. Where will an interchangeable biosimilar have the most impact? An interchangeability rating may result in the perception that the product is superior in quality to other biosimilars.How will payors react? Likely competitor response