, Aug. 30, 2012
/PRNewswire/ -- Novation applauds the recent approval by the U.S. Food and Drug Administration of Sicor Biotech's tbo-filgrastim and the important milestone it represents in the continued development of biosimilar pharmaceuticals in the United States
. Although approved through a full Biologics License Application and not a formal "biosimilar", this product is expected to fill the same role in clinical practice as subsequent biosimilars that are ultimately approved via the abbreviated pathway, signed into law in 2010. Sicor Biotech is expected to begin marketing tbo-filgrastim in November 2013.
Biosimilars, which are 'highly similar' versions of reference biologics, are currently approved for use in the European Union and other regions. Research suggests that use of biosimilars could result in price decreases of 20 to 30 percent.
"Despite the slower pace of development in the U.S., biosimilars represent a much needed opportunity for lower-cost alternatives to commonly used biologics as hospitals struggle to contain drug related expenditures," said Steven Lucio, PharmD, BCPS, director of clinical solutions, pharmacy, Novation. "Both this product and subsequently approved biosimilars will require a great deal of physician, pharmacist and clinical staff education to ensure appropriate use and meaningful uptake in the US market. Novation is committed to serving as a resource to help healthcare providers prepare for biosimilars and maximize their impact."
The FDA approved Sicor's tbo-filgrastim as a treatment for patients receiving cancer chemotherapy who experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils.
Novation, the health care industry's leading supply contracting company for the members and affiliates of VHA Inc, UHC and Provista, has actively monitored the development process for biosimilars, and how biosimilars have progressed in Europe to identify keys issues for hospitals considering biosimilar therapies.
Previously, Novation released a series of white papers, "Biosimilars FDA Guidance Update," and "Preparing for Biosimilars," in 2011 and May 2012 to help hospitals and health care providers better understand the key components of the FDA's draft guidance and the potential impact of biosimilar usage as they gain broader adoption in the United States.
Please visit https://www.novationco.com/media/white_papers.asp for more information and to view the reports.
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, Children's Hospital Association, an alliance of the nation's leading pediatric facilities, 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. To learn more about Novation, please visit www.novationco.com and follow @NovationNews.