Biological Product Innovation and Competition

Biological products (biologics) are the fastest-growing class of medications in the United States and account for a substantial and growing portion of health care costs. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated approval pathway to help provide patients with greater access to safe and effective biological products. FDA’s Biosimilars Action Plan (BAP) outlines FDA’s commitment to encouraging innovation and competition for biologics and to facilitating the development of safe and effective biosimilar and interchangeable biosimilar products at potentially lower costs for patients.

Learn more about FDA’s role in helping to ensure that the United States remains a driving force in medical innovation while encouraging competition to lower costs and increase patient access to medications.

How does the BPCI Act promote the balance between innovation and market competition?

Learn More About Biological, Biosimilar, and Interchangeable Products

View and download our fact sheets for health care providers.

• Overview of Biosimilar Products
• Biosimilar Regulatory Review and Approval
• Interchangeable Biological Products

The BPCI Act established a framework to promote both innovation and competition. The BPCI Act promotes innovation by providing a period of exclusivity for originator biologics. The BPCI Act also promotes competition once exclusivity periods have expired by enabling a potentially quicker and less costly pathway for approval of biosimilars and interchangeable biosimilars, without compromising safety and effectiveness.

By increasing treatment options, biosimilars can enhance competition in the market for biological products.

What key actions is FDA taking to encourage innovation and competition in the development of biological products, including biosimilar and interchangeable biosimilar products?

To encourage innovation and competition in the market for biological products and facilitate the development of biosimilars and interchangeable biosimilars, FDA focuses on four key areas outlined in the BAP:

• Improving the efficiency of the biosimilar and interchangeable biosimilar product development and approval process
• Maximizing scientific and regulatory clarity for the biosimilar product development community
• Developing effective communications to improve understanding of biosimilars and interchangeable biosimilars
• Supporting adoption of biosimilars, identifying false or misleading statements about biosimilars, and deterring anti-competitive practices in the biological product marketplace

To learn more about all of FDA’s goals and accomplishments within the four key areas, read more on the Biosimilars Action Plan page.