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PAREXEL Consulting Thought Leaders Provide Insights Into U.S. Biosimilar Development and Monoclonal Biosimilars in Two New White Papers
Date:9/22/2010

BOSTON, Sept. 22 /PRNewswire/ -- PAREXEL Consulting, a business unit of PAREXEL International (Nasdaq: PRXL) and leading global life sciences consultancy serving the biopharmaceutical and medical device industries, today released two new white papers from leading biosimilar experts that provide key insights into emerging areas of biosimilar development. The white papers, authored by Bruce Babbitt, Ph.D., Principal Consultant and Cecil Nick, B.Sc. (Hons), Vice President, Biotechnology, both of PAREXEL Consulting, are respectively entitled "The Dawn of Biosimilar Development in the U.S.:  Key Legislative Aspects and Next Steps for Biopharma Manufacturers" and "How Can the Biosimilar Concept Be Applied to More Complex Proteins Such as Monoclonals?"

"With the passage of the Biologics Price Competition and Innovation Act of 2009 as part of healthcare reform, there is now a legal basis and provisions to enable the establishment of a regulatory pathway to guide the development of biosimilars in the U.S.  As a result, we expect to see more companies initiating global development of a wide array of biosimilar products that have the potential to provide more cost effective medicines to patients," said Dr. Babbitt.  "Companies need to discuss their development plans with regulatory authorities and then decide on a case-by-case basis whether to participate in the biosimilar opportunity or forego it in favor of the traditional biologics license application pathway."

"The Dawn of Biosimilar Development in the U.S.:  Key Legislative Aspects and Next Steps for Biopharma Manufacturers" provides key factors for companies to consider as they prepare to schedule formal meetings with the U.S.
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