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Regulatory IP:

Essentials of Lifecycle Management

The lifecycle management tools covered in this guide will help enhance value for biopharmaceutical investors, developers, and manufacturers and strengthen the incentives for continued medical progress.

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Gregory Glover | Blog

August 16, 2024

FDA Proposes Dropping Switching Studies for Biosimilar Interchangeability

On June 20, FDA issued a draft guidance proposing to remove switching studies from the interchangeable biosimilar approval process. The draft guidance eliminates the longstanding recommendation that biosimilar developers provide clinical data showing... More

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