Biosimilars Conference

The term “interchangeable,” when applied to biosimilars, has different meanings in different parts of the world. The session will begin with a review of terminology, including differences in US and EU definitions of interchangeability, and regulatory and legal frameworks as they relate to substitution of biologics. The session will then explore the US FDA draft guidance for industry on considerations in demonstrating interchangeability with a reference product, highlighting data expectations, and relaying industry perspectives on demonstrating interchangeability; discussing combination product considerations; and sharing perspectives on value and implementation in the US.