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 products at potentially lower costs for patients.

Learn more about how FDA helps 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?
• What key actions is FDA taking to encourage innovation and competition in the development of biological products, including biosimilar and interchangeable products? 

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

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 act also promotes competition once exclusivity periods have lapsed by enabling a potentially quicker and less costly pathway for approval of biosimilar and interchangeable products, 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 product development and approval process
• Maximizing scientific and regulatory clarity for the biosimilar product development community
• Developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors
• Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition

Improving the efficiency of the biosimilar and interchangeable product development and approval process

FDA is working to improve efficiency and predictability in the biosimilar and interchangeable product development and review process. Examples of these efforts include the following:

• Developing application review templates specifically for 351(k) Biologics License Applications (BLAs)
• Creating informational resources to help sponsors better understand the FDA evaluation process and data recommendations, such as product-specific and other scientific guidance 
• Developing tools and initiating research on the use of pharmacodynamic biomarkers for biosimilar and interchangeable product development:
  • September 20-21, 2021: Pharmacodynamic Biomarkers for Biosimilar Development and Approval, a public workshop to discuss the current and future role of pharmacodynamic (PD) biomarkers in improving the efficiency of biosimilar product development and approval 

Maximizing scientific and regulatory clarity for the biosimilar product development community

FDA is increasing its communications with stakeholders regarding the development, review, and approval of biosimilar and interchangeable products. These efforts include the following:

• Developing guidance to further clarify the regulatory pathway and provide recommendations on scientific approaches to meeting requirements for biosimilar and interchangeable products
• Enhancing the Purple Book to include more information about approved biological products and provide a modernized, interactive user experience 
• Strengthening FDA’s partnerships with international regulatory authorities to support an efficient global market
• Leveraging real-world data to support regulatory decision making related to biosimilars, when possible
• Engaging in public hearings and requesting additional information from the public to help FDA enhance its biosimilar program: 
  • September 4, 2018: Facilitating Competition and Innovation in the Biological Products Marketplace, a public hearing
  • May 13, 2019: The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products, a public hearing

Developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors

FDA is taking a proactive role to educate clinicians, patients, and payors about biosimilar and interchangeable products. These efforts include the following:

• Offering a variety of outreach materials that convey key concepts about biosimilar and interchangeable products for health care professionals, such as:
  • Definitions of biosimilars, reference products, and interchangeable biosimilars
  • The review and approval process for biosimilars and interchangeable biosimilars
• Developing resources for patients to build a basic understanding of biosimilars and the FDA approval process
• Engaging stakeholders, such as health care professional groups, payors, and patient advocacy organizations, through efforts such as:
  • Participation in conferences and meetings
  • Continuing education credit webinars on biosimilar and interchangeable products
• Developing curriculum materials for health care programs for students in degree programs, as well as practicing professionals, to improve their understanding of biosimilar and interchangeable products

Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition

FDA will continue to evaluate consistent with its authority whether manufacturers are inappropriately delaying the approval of biosimilar or interchangeable competitors. This includes:

• Working with partners across the government, such as the Federal Trade Commission (FTC), to take appropriate action within their respective authorities where necessary and appropriate: 
  • Holding FDA/FTC Workshop on a Competitive Marketplace for Biosimilars, a public workshop to discuss FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and deter anticompetitive behaviors in the biological product marketplace
  • Issuing a Joint Statement of FDA and FTC Regarding a Collaboration to Advance Competition in the Biologic Marketplace
• Working with legislators, as needed, to close any loopholes that may effectively delay biosimilar competition beyond the exclusivity periods envisioned by Congress
• Addressing circumstances in which biologic makers use anticompetitive strategies to delay the market entry of biosimilar and interchangeable products

FDA anticipates that the marketplace for biosimilar and interchangeable products will continue to evolve. The Agency will continue to work to maximize regulatory clarity and to keep pace with advances in science and technology that support biological product development.