PAREXEL Consulting releases two new white papers on biosimilar development

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: https://www.parexel.com/