On Tuesday, the U.S. FDA finalized three biosimilar guidance documents which had first been released in draft form three years.
As reported by RAPS, the three finalized guidance docs include:
1) Guidance for Industry - Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
This is a question-and-answer document outlining how FDA interprets the BPCI, including its provisions on exclusivity, biosimilarity and interchangeability.
2) Guidance for Industry - Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
This document details quality considerations drugmakers need to take into account when attempting to demonstrate biosimilarity between a biosimilar product and its reference product.
3) Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
This document explains FDA's recommended approach for demonstrating biosimilarity using scientific data.