Biosimilars Action Plan
To encourage innovation and competition in the market for biological products and facilitate the development of biosimilars and interchangeable biosimilars, FDA has developed the Biosimilars Action Plan (BAP). The plan outlines the Agency’s commitments and focuses on efforts that support these objectives.
Read the FDA Voices blog about FDA’s 50th biosimilar approval. This milestone reflects our strategic approach to biosimilars, as outlined in the FDA’s Biosimilars Action Plan.
The BAP, first released in 2018 in a report format, was organized by four key areas and contains priority deliverables to meet the goals outlined in the BAP. Over the past 5 years, FDA has accomplished most of the goals in the 2018 BAP and released a 2018 Biosimilars Action Plan Summary Report to provide a detailed account of these deliverables and activities.
To further support the work FDA is doing related to biosimilars, FDA has updated the 2018 BAP to modernize the Agency’s strategic priorities and to align with the regulatory goals outlined in current Biosimilar User Fee Act (BsUFA) commitments. The updated BAP is streamlined and presented here in a web-based format and serves as the blueprint for achieving FDA’s mission for biosimilars. It is organized by overarching “Goals” and targeted “Aims” that describe the high-level vision to support FDA’s continued efforts to encourage innovation and competition for biologics and to facilitate the development and approval of high quality, safe, and effective biosimilar and interchangeable biosimilar products for the American public.
Biosimilars Action Plan: Goals and Aims
Goal 1: Improving the efficiency of the biosimilar and interchangeable biosimilar product development and approval process.
FDA is working to improve efficiency and predictability in the biosimilar and interchangeable biosimilar development and review process. The following Aims support this goal:
- Aim 1.1: Refine review-related process and practice.
- Aim 1.2: Enhance communication and consistency of development and review-related procedures.
Deliverables:- Updates to Draft Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products to align with BsUFA III commitments.
- Draft Guidance: Classification Categories for Certain Supplements Under BsUFA III.
- Aim 1.3: Streamline clinical development programs.
Deliverables- FDA/IPRP Workshop: Increasing the Efficiency of Biosimilar Development Programs—Reevaluating the Need for Comparative Clinical Efficacy Studies
- FDA’s Research in Biomarkers and Their Role in Biosimilar Product Development
Goal 2: 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 biosimilar products. The following Aims support this goal:
The Purple Book is a database that contains information about all FDA-licensed biological products regulated by CDER. See the FAQ page in the Purple Book for more information.
- Aim 2.1: Develop and update guidances to maximize scientific and regulatory clarity for the product development community.
Deliverables- Draft Guidance: Labeling for Biosimilar and Interchangeable Biosimilar Product
- Aim 2.2: Enhance science-based regulatory recommendations and decision-making.
- FDA is piloting a regulatory science program to (1) advance the development of interchangeable biosimilar products and (2) improve the efficiency of biosimilar product development.
- Released the first draft of the BsUFA III Research Roadmap in January 2023, collected comments in an open public docket, and released the Revised Research Priorities in January 2024.
- FY22 - FY23 Regulatory Research Pilot Program Research Awards
- Held a two-part meeting to discuss the revised research roadmap and the direction of the Regulatory Science Pilot Program in October 2023.
- Aim 2.3: Enhance communication and clarity about key biological product information.
Deliverables- Updated the Purple Book: Database of Licensed Biological Products to include information regarding marketing status reports from license holders.
- Aim 2.4: Continue to collaborate with international regulatory authorities to facilitate global development of biosimilars.
Deliverables- Participate in the International Pharmaceutical Regulators Programme and Chair its Biosimilars Working Group.
- Regularly meet with international regulatory authorities through the Biosimilars Cluster.
Goal 3: Developing effective communications to improve understanding of biosimilars and interchangeable biosimilars.
FDA is taking a proactive role to educate clinicians, patients, and payors about biosimilar and interchangeable products. The following Aims support this goal:
Read the FDA Voices blog about FDA and FTC’s collaboration to advance competition for biologics.
- Aim 3.1: Develop educational materials for stakeholders, such as health care providers, patients, caregivers, advocates, payors, other government agencies, and regulated industry.
Deliverables:- On March 2, 2023, FDA and the Federal Trade Commission (FTC) released an educational resource for consumers about biosimilars and interchangeable biosimilars to help address common misperceptions, especially about interchangeable biosimilars.
- On March 21, 2023, FDA released an updated infographic and two new fact sheets for patients in English and Spanish, including one for patients with diabetes.
- On June 6, 2023, FDA released three new animated videos for health care providers to learn more about biosimilars and interchangeable biosimilars.
- On July 11, 2023, FDA released a new animated video for patients about biosimilars.
- Aim 3.2: Engage in external outreach and education with stakeholders, such as health care providers, patients, caregivers, advocates, payers, other government agencies, and regulated industry.
Deliverables:- Held a Reddit Ask Me Anything on the “r/pharmacy” forum to answer questions from the public about biosimilars and interchangeable products on June 7, 2023.
- Conduct stakeholder outreach through webinars, presentations, and conference participation.
Goal 4: Supporting adoption of biosimilars, identifying false or misleading statements about biosimilars, and deterring anticompetitive behaviors in the biological product marketplace.
FDA will continue to evaluate, consistent with its authority, whether manufacturers are inappropriately delaying the approval of biosimilar or interchangeable competitors. 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. The following Aims support this goal:
- Aim 4.1: Continue to assess whether manufacturers are inappropriately delaying the approval of biosimilar or interchangeable competitors and take mitigating actions, consistent with FDA’s authority.
- Aim 4.2: Continue to identify and counteract misinformation about biosimilar and interchangeable biosimilar medications.
Deliverables:- On March 2, 2023, FDA and FTC released a report from the public workshop titled, “Summary Report on the FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.”