Fact Sheet

Data Exclusivity for Biologics

PhRMA December 1, 2015

Biologic medicines have resulted in and will continue to result in tremendous medical advances against the most challenging and costly diseases affecting American patients. The Biologics Price Competition and Innovation Act, which was broadly supported by both sides of the aisle in both the House and Senate, created an abbreviated approval pathway for biosimilars (biologics that are similar to innovative biologics), as well as provided a 12-year period of data protection for innovator biologics – striking an appropriate balance between making room for additional competition and maintaining incentives for continued innovation. Data protection is critical to ensuring continued medical progress, R&D investment, and economic growth. Reducing data protection for innovator biologics could reduce R&D investment in the U.S. and could shift high-value, high-wage R&D jobs to other countries with more favorable intellectual property policies.