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

$397.00
Quantity Discounts
1 - 2
$397.00
3 - 4
$357.00
5 - 6
$337.00
7 - 9
$317.00
10 - 9999
$297.00
Also Available:

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.


Order Your Copy Today

PDF Edition

Print Edition

 

Available Formats

PDF Edition — $397
Print Edition — $397

(Add $10 shipping and handling per book for printed books shipped to the US or $35 per book for books shipped elsewhere. VA residents, please add 6 percent sales tax.)

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

Multi-user Access

Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.

Our Guarantee

Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price. Return the hard copy within 30 days (in resalable condition) to receive your refund (less shipping/handling).