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Strategies for Biosimilars Approval: A Map to 351(k) Success
Strategies for Biosimilars Approval A Map to 351(k) Success
Want to know how Sandoz was the FDA’s first biosimilar approval? Learn how Sandoz navigated the agency's approval process.
FDAnews has a new management report that will give you candid "what to do — and how to do it" advice, including:
The evolution of the FDA’s thinking on the clinical requirements for showing biosimilarity, right up to and including the 2015 guidance
How participating in the FDA's Biological Product Development Program (BPDP) can benefit you and your company
The supporting clinical data you MUST include in your filings to gain approval quickly
The correct way to apply the FDA's latest recommendations for demonstrating that a proposed product is "highly similar" to a reference
How to effectively use key evaluations and modeling and simulation tools
Anticipating legal and regulatory hurdles such as patent and litigation issues, interchangeability and state substitution laws
You also get a detailed review of 4 critical topics from the recent FDA guidance:
How to establish a step-wise approach to product development — the way the FDA prefers
The agency’s "totality of evidence" methodology for assessing 351(k) applications
Using foreign reference products and the need for bridge studies
How analytics should be designed for pharmacokinetics and pharmacodynamics
Discover how to minimize the amount of time it takes to get your biosimilars approved — so you can speed your product to market and maximize your revenue generating potential.
Order Strategies for Biosimilars Approval: A Map to 351(k) Success TODAY.
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PDF Edition
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Table of Contents
Introduction
Regulatory Framework for Biosimilars
How to Prepare a 351(k) Application for FDA Approval
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