Large Molecule / Regulatory Guidance

FDA Finalizes Three-Year Old Biosimilar Guidance

Source: RAPS

Apr 30, 2015

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.

See the RAPS article for indepth discussion