Anything You Can Do I Can Do (Better?): Demonstrating Biosimilar Interchangeability

Anything You Can Do I Can Do (Better?): Demonstrating Biosimilar Interchangeability

Source: 
FDA Law Blog
snippet: 

FDA recently finalized its guidance document intended to assist protein biosimilar manufacturers in demonstrating interchangeability, Considerations in Demonstrating Interchangeability With a Reference Product.  Interchangeability, as of now, is nothing more than a pipe dream; no biosimilar has been declared interchangeable and therefore fully substitutable for its reference product.  But FDA is hoping that this guidance will help address that.