Issues and Challenges in the Clinical Development of Biosimilars

• Activity Number: 393
• Type: Topic Contributed
• Date/Time: Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Patrick FitzGerald Darken*+ and Steve Barash
• Companies: Teva Branded Pharmaceutical Product R&D, Inc. and Teva Branded Pharmaceutical Product R&D, Inc.
• Keywords: Biosimilar ; Clinical Development

Abstract

In order to reduce health care costs, the development of biosimilar products has received a lot of attention lately both in the US and Europe. A legal pathway for approval of biosimilar products has existed since 2004 in Europe with specific scientific guidelines being issued starting in 2006. Now with the passage of the Patient Protection and Affordable Care Act in March of this year, although the detailed scientific requirements still need to be sorted and clarified, a legal pathway exists in the US for the approval of biosimilar and substitutable products. Issues and challenges associated with the clinical development of biosimilar products for both the European and US markets will be discussed. These include the selection of endpoints, setting of margins, establishment of biosimilarity, use of historical controls, and the use of sequential and adaptive designs.