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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

Food and Drug Administration (FDA) to discuss biosimilar product development programs.  According to Dr. Babbitt, a well-defined regulatory pathway for biosimilars has been operating in Europe since 2005, and the U.S. is now poised to enter this marketplace.  As noted in the white paper, the FDA is planning to spend $5.7 million in Fiscal 2011 to develop drug review standards specific for biosimilars.  In addition, key aspects of the legislation are discussed as well as how biosimilarity and potentially interchangeability to innovator products is to be demonstrated.

"How Can the Biosimilar Concept Be Applied to More Complex Proteins Such as Monoclonals?" further examines the potential development of biosimilar versions of approved mAbs. The white paper addresses the robustness of the mAb market, which is anticipated to increase at a compound annual growth rate of nearly 11 percent, and discusses approval pathways for biosimilar mAbs that could propel the biosimilars market. The white paper reviews the complex structure of mAbs, the value of nonclinical data, new thinking required in early development and the challenges of confirmatory efficacy trials.

"Demonstrating therapeutic equivalence for monoclonals will be challenging and companies will need to consider their options carefully," said Mr. Nick. "The biosimilar industry along with regulators will need to apply state of the art methodologies and novel approaches for biosimilar monoclonals to become a reality."

The white papers, part of PAREXEL Consulting's Intelligent Development Series, which provides data and insights in support of successful biopharmaceutical and medical device product development, are available at: http://www.PAREXEL.com/services-and-capabilities/consulting/our-thinking/whitepapers.

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