Scientific Considerations in Demonstrating Biosimilarity to a Reference Product - FDA Draft Guidance
| Provides guidance to companies which must demonstrate the boisimilarity of a therapeutic protein product to a existing reference product. The guidance recommended a stepwise risk-based "totality-of-the-evidence" approach to evaluate the biosimilarity to the reference product relating to structure, function, animal toxicity pharmacokinetics and pharmacodynamics, clinical immunogenicity, and clinical safety and effectiveness. |
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