FDA Introduces Biosimilar Action Plan

On July 18, the U.S. Food and Drug Administration (FDA) introduced its Biosimilar Action Plan (BAP) to help speed up approvals to enhance access to lower-cost biologics. With biologics representing 40 percent of all prescription drug spending, FDA says it is trying to better manage review and licensure pathways to facilitate competition and modernize policies to make review more efficient. According to Scott Gottlieb, FDA’s commissioner, the BAP seeks to preserve the “balance between innovation and competition [through] efficient, predictable and science-based pathways for drug review.”

Specifically, the BAP focuses on four areas: efficiency of development and approval; scientific and regulatory clarity; effective communication; and reducing gaming of FDA requirements or other delays in competition. As part of the BAP, FDA is:

• Developing and implementing new FDA review tools such as standardized review templates for biosimilar and interchangeable products;
• Creating information resources and development tools for biosimilar sponsors; • Enhancing the Purple Book to make it more useful;
• Exploring data-sharing agreements with foreign regulatory authorities to facilitate increased use of non-U.S.-licensed comparator products;
• Establishing an Office of Therapeutic Biologics and Biosimilars;
• Continuing to provide education to healthcare professionals about biosimilar and interchangeable products;
• Publishing guidance on biosimilar product labeling;
• Providing additional clarity on demonstrating interchangeability;
• Providing additional support to product developers regarding product quality and manufacturing processes; and
• Engaging in public dialogue about the biosimilar program

Additionally, FDA has committed to holding public meetings and hearings, as well as prioritizing the development of guidance on various aspects of the Biologics Price Competition and Innovation Act.