Friday, 5 June 2015

FDA: Biosimilarity to a Reference Product

The U.S. Food and Drug Administration has issued a new guidance document titled "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product."

The document is concerned with providing a stepwise approach to demonstrating biosimilarity, which can include a comparison of the proposed product and the reference product with respect to structure, function, animal toxicity, human pharmacokinetics (PK) and pharmacodynamics (PD), clinical immunogenicity, and clinical safety and effectiveness. Areas covered include:

  • Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product
  • Scientific Considerations in Demonstrating Biosimilarity to a Reference Product • Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 • Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants • Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

For further details see FDA.

Posted by Tim Sandle