GUIDE:

Navigating FDA’s New Biosimilar Pathway: Replacing Clinical Efficacy Trials with Bioanalytical Data

The FDA has officially shifted its expectations for biosimilar development, and clinical efficacy studies may no longer be required.

In this guide, we break down what these changes mean for drug developers and how to build a totality-of-evidence package that satisfies regulators while accelerating development timelines.

What's inside:

• A breakdown of assays that can replace clinical efficacy studies
• A CMC, PK, and immunogenicity readiness checklist aligned with the FDA’s new framework
• Tools to help you align your team, timeline, and testing strategy to regulatory expectations
  

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