FDA Issues Draft Guidance on Biosimilars

In a press release today, the FDA announced the publication of three draft guidance documents on biosimilar product development "to assist industry in developing such products in the United States."  FDA is seeking public comment on the draft guidance documents.

The three guidance documents are:

1. Scientific Considerations in Demonstrating Biosimilarity to a Referenced Product--intended to assist companies in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product.
2. Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product--provides an overview of analytical factors to consider when assessing biosimilarity between a proposed therapeutic protein product and a reference product.
3. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009--provides answers to common questions that may arise in the early stages of product development.