Last month, the FDA published the draft guidance “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.”
This guidance, focused on therapeutic proteins, provides an overview of key scientific considerations for determining when a Clinical Efficacy Study (CES) may be useful in supporting a demonstration of biosimilarity.
With this draft, the FDA presents an updated framework for assessing when a CES may not be necessary to support biosimilarity.
The Agency recommends that sponsors carefully evaluate which clinical studies are truly needed when designing their development programs. In general, if the Comparative Analytical Assessment (CAA) demonstrates that the proposed biosimilar is highly similar to its reference product—except for minor differences in clinically inactive components—then:
- An appropriately designed human pharmacokinetic similarity study, and
- An assessment of immunogenicity
may be sufficient to determine whether there are any clinically meaningful differences between the proposed biosimilar and the reference product in terms of safety, purity, and potency, without requiring a clinical efficacy study.
Read the full guide here: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
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