Strategies for Biosimilars Approval: A Map to 351(k) Success

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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:

  1. How to establish a step-wise approach to product development — the way the FDA prefers

  2. The agency’s "totality of evidence" methodology for assessing 351(k) applications

  3. Using foreign reference products and the need for bridge studies

  4. 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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Table of Contents

  • Introduction
  • Regulatory Framework for Biosimilars
  • How to Prepare a 351(k) Application for FDA Approval
  • Anticipating Legal and Regulatory Hurdles
  • And More …

View the entire TOC

Who Will Benefit

  • Drug company executives
  • Biotech company executives
  • Clinical project specialists
  • Product life-cycle specialists
  • Pharmacokineticists
  • Clinical pharmacologists
  • Medical affairs specialists
  • Clinical data management and statistics personnel
  • R&D staff
  • Regulatory affairs professionals
  • Submission and approval specialists
  • IP/general/corporate counsel
  • Consultants/service providers

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