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Novation Applauds New FDA Guidance Documents on Biosimilars
Date:2/15/2012

IRVING, Texas, Feb. 15, 2012 /PRNewswire/ -- The publication of three guidance documents by the Food and Drug Administration represents a significant milestone in the biosimilar development process and provides the infrastructure by which pharmaceutical manufacturers can seek approval for lower cost, clinically comparable alternatives to some of the most commonly utilized biologic agents purchased by health care organizations.     

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 keys issues members will have to address when considering how to use biosimilars.    

In recent years, an increasing amount of hospital pharmaceutical expense is being devoted to the acquisition of high cost, large molecule biologics, which historically have not been subject to "generic" competition because they are complex to manufacture and are derived from living organisms.  Biosimilars, or drugs that clinical studies deem "highly similar" to these large molecule biologics, will provide effective, safe, and cost-efficient alternatives to expensive, current biologic drugs.  

Based upon the experience in the European biosimilars market, these "highly similar" versions of reference biologics could result in price decreases of 20% to 30%.  "However, adoption of biosimilars will be a more complex process and will require greater physician involvement in contrast to what traditionally happens with small molecule generics," said Steven Lucio, director of pharmacy clinical solutions for Novation.  "Health care organizations will have to devote more resources to the evaluation of these products. Therefore, it is critically important for Novation to provide the
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SOURCE Novation
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