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.
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:
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.
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Aim 2.1: Develop and update guidances to maximize scientific and regulatory clarity for the product development community.
Deliverables -
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.
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Aim 2.3: Enhance communication and clarity about key biological product information.
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Aim 2.4: Continue to collaborate with international regulatory authorities to facilitate global development of biosimilars.
Deliverables
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.
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Aim 3.1: Develop educational materials for stakeholders, such as health care providers, patients, caregivers, advocates, payors, other government agencies, and regulated industry.
Deliverables: -
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.
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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.”
