FDA recently finalized three draft guidance documents addressing scientific and regulatory issues associated with the development and licensure of biosimilars:
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product advises sponsors to consider the complexities of protein products when designing programs to demonstrate biosimilarity, discusses a "stepwise" approach sponsors should use in developing the evidence needed to support biosimilarity, and advises sponsors that FDA will use a totality-of-the-evidence approach to assess a demonstration of biosimilarity.
- Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product focuses on scientific and technical information for the chemistry, manufacturing, and controls section of a biosimilar application. The guidance discusses limitations of current technology in characterizing structural and functional differences between the two protein products and identifies factors to consider in assessing whether products are highly similar, including manufacturing process, physicochemical properties, functional activities, receptor binding, impurities, reference standards, and stability.
- Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 ("BPCIA") provides answers to common questions regarding FDA's interpretation of the BPCIA, in three categories including permissible differences between biosimilars and reference products, meeting the amended definition of a "biological product" and how "product class" is defined, and orphan exclusivity for biosimilar products.
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