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. FDA 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:- Final Guidance: Classification Categories for Certain Supplements Under BsUFA III, September 2025.
- Updates to Final Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products to align with BsUFA III commitments, July 2025.
- Aim 1.3: Streamline clinical development programs.
Deliverables:- Draft Guidance: New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4), March 2026.
- Draft Guidance: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies, October 2025.
- Draft Guidance: Considerations in Demonstrating Interchangeability With a Reference Product: Update, June 2024.
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: Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts, July 2026.
- Draft Guidance: Labeling for Biosimilar and Interchangeable Biosimilar Products, September 2023.
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.
Deliverables:
- Held a BsUFA III Regulatory Science Program Interim Public Meeting and published an Interim Report in 2025.
- Held a Public Workshop: Future Needs for the Development of Interchangeable Products in September 2025 and published a Post-Workshop Strategy Document.
- Held a two-part meeting to discuss the revised research roadmap and the direction of the Regulatory Science Pilot Program in October 2023.
- 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.
- Regulatory Research Pilot Program Research Awards
- 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.
- IPRP paper on Regulatory Perspectives on the Utility of Comparative Efficacy Studies in Biosimilar Development Programs, February 2026.
- Developing the ICH M18 Guideline: Framework for Determining the Utility of Comparative Efficacy Studies in Biosimilar Development Programs. The final concept paper was released in November 2025.
- FDA/IPRP Workshop and Summary Report: Increasing the Efficiency of Biosimilar Development Programs—Reevaluating the Need for Comparative Clinical Efficacy Studies, September 2023.
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:- FDA, through Medscape, has released multiple continuing education materials for health care providers on an ongoing basis. (Please note: a free Medscape login is required to access these activities.)
- On December 16, 2024, FDA released updated Curriculum Materials for Health Care Degree Programs.
- On July 11, 2023, FDA released a new animated video for patients about biosimilars.
- On June 6, 2023, FDA released three new animated videos for health care providers to learn more about biosimilars and 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 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.
- 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" (June 7, 2023) and "r/medicine" (June 6, 2024) forums to answer questions from the public about biosimilars and interchangeable products.
- 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:- In December 2025, FDA released the final guidance for industry Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers.
- 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."