PAREXEL Consulting Thought Leaders Provide Insights Into U.S. Biosimilar Development and Monoclonal Biosimilars in Two New White Papers

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. 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.

About PAREXEL International

PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement.  Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.  Headquartered near Boston, Massachusetts, PAREXEL operates in 70 locations throughout 54 countries around the world, and has approximately 9,720 employees. For more information about PAREXEL International visit www.PAREXEL.com.

This release contains "forward-looking" statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand.   For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements.  Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "intends," "appears," "estimates," "projects," "will," "would," "could," "targets," and similar expressions are also intended to identify forward-looking statements.  The forward-looking statements in this release involve a number of risks and uncertainties.  The Company's actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release.  Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent and anticipated restructurings, the loss, modification, or delay of contracts which would, among other things, adversely impact the Company's recognition of revenue included in backlog; the Company's dependence on certain industries and clients; the Company's ability to win new business, manage growth and costs, and attract and retain employees; the Company's ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; the impact on the Company's business of government regulation of the drug,  medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks.   Such factors and others are discussed more fully in the section entitled "Risk Factors" of the Company's Annual Report on Form 10-K for the year ended June 30, 2010 as filed with the SEC on August 27, 2010, which "Risk Factors" discussion is incorporated by reference in this press release.  The Company specifically disclaims any obligation to update these forward-looking statements in the future.  These forward-looking statements should not be relied upon as representing the Company's estimates or views as of any date subsequent to the date of this press release.

PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.

SOURCE PAREXEL International Corporation