News | May 10, 2012

High Expectations For New U.S. Biosimilar Pharmaceuticals Following FDA Guidance Documents

Use of Biosimilars in European Markets Signal Potential for Significant Savings for America's Hospitals

Irving, TX  /PRNewswire/ -  In light of the upcoming FDA guidance for biosimilar approval, Novation has released a white paper, "Biosimilars – FDA Guidance Update," to help hospitals and health care providers better understand the key components of the FDA's draft guidance documents and suggested next steps.  Building on its previous white paper "Preparing for Biosimilars," published in November 2011, the aim of Novation's report is to help providers have a deeper understanding of the potential value and impact of biosimilar usage as they gain broader adoption in the United States.

"Experience with biosimilars in the European Union suggests that these 'highly similar' versions of reference biologics could result in price decreases of 20 to 30 percent," said Steven Lucio, PharmD, BCPS, director of clinical solutions, pharmacy, Novation. "In spite of the uncertainty about the exact timing of biosimilar availability, lower-cost alternatives to commonly used biologics will receive market approval in the near future."

The paper includes a discussion of key elements of the FDA's guidance including:

  • How the biosimilar pathway compares to the development of a new molecular entity;
  • FDA's expectation for structural and functional characterization to serve as the foundation for any biosimilar application;
  • The scientific and quality considerations needed to demonstrate biosimilarity to a reference protein product;
  • Answers to common questions FDA has received in its preliminary discussions with potential biosimilars applicants; and
  • The pharmaceutical industry's response to the guidance documents and next steps for hospitals. 

In February 2012, the Food and Drug Administration (FDA) published three guidance documents which were a significant milestone in the biosimilar development process because they provide the infrastructure by which pharmaceutical manufacturers can seek approval for lower cost, clinically comparable alternatives to some of the most commonly utilized biologic agents used by health care organizations to treat patients.  The guidance documents have been made available for open comment, and the FDA will conduct a one-day hearing on May 11 to obtain more input from the public.

Novation, the health care industry's leading supply contracting company for the members and affiliates of VHA Inc, UHC and Provista, has been actively monitoring the development process for biosimilars, improving its understanding of how biosimilars have progressed in Europe and identifying the key issues for hospitals when considering how to use biosimilars.   

"Hospitals must prepare for the arrival of this new class of drugs because unlike generic small molecules, evaluation of biosimilars will require the input of physicians, pharmacists, nurses and even patients," said Lucio. "Novation is committed to providing the information health care providers need to conduct complete and comprehensive evaluations of these products, including drug monographs, comparison charts and sample presentations."

To view the entire report, please visit

About Novation, Winner of the Ethics Inside® Certification
Founded in 1998, Novation is the leading health care supply chain expertise and contracting company for the more than 65,000 members of VHA Inc. and UHC, two national health care alliances, and Provista, LLC. Novation provides alliance members with sourcing services, as well as information and data services. Based in Irving, Texas, Novation develops and manages competitive contracts with more than 600 suppliers. VHA, UHC, and Provista members used Novation contracts to purchase more than $40 billion in 2011. Novation recently earned the coveted Ethics Inside® Certification from Ethisphere Institute, a leading international think tank dedicated to the research and promotion of best practices in corporate ethics and compliance.  Novation was also named on Ethisphere's World's Most Ethical Companies list, and is the only company in the health care industry to earn both distinctions.

SOURCE Novation


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