High expectations for new U.S. biosimilar pharmaceuticals following FDA guidance documents

May 10, 2012 2:55 PM

In light of the upcoming FDA guidance for biosimilar approval, Novation, a health care supply contracting company 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– FDA Guidance Update,” to help hospitals and health care providers better understand the key components of the FDA’s draft guidance documents and suggested next steps.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, 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 tomorrow to obtain more input from the public.

“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.”

The full report can be accessed from here:


Source: Novation press release

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