The Biologics Price Competition and Innovation Act: How to Move Forward in the New Regulatory Environment

Presentation details:
With the recent passage of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) on March 23, 2010, there is now an abbreviated regulatory pathway for biosimilar products. Companies need to prepare their development program and meet with the Food and Drug Administration (FDA) to obtain concurrence on the data requirements to obtain FDA approval of an abbreviated Biologics License Application (BLA). It is especially important for global developers of these products targeting the U.S. market to ensure that their preclinical and clinical development plans satisfy both U.S. and ex-U.S. (primarily European) regulatory requirements.

In this TeleBriefing, professionals in the areas of life sciences law and biotechnology development will address the diverse challenges and issues related to the design and performance of a global biosimilar development program which optimally integrates the changing legal and regulatory landscape. The program will explore the intricacies of the BPCIA, as well as the uncertainties that lie ahead, and will provide a framework for embarking on a Biosimilars development path.