Industry Information and Guidance
Learn more about FDA’s resources to provide manufacturers with information on the review and approval process for biosimilar and interchangeable products.
- Guidance for Industry
- Biosimilars Action Plan
- Biosimilar User Fees
- Office of Therapeutic Biologics and Biosimilars
- Congressional Testimony and Legislation
- Educational Resources
- Contact Us
Guidance for Industry
FDA provides guidance on demonstrating biosimilarity and interchangeability, biosimilar regulatory review and approval, and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), by publishing guidance documents. To search for specific guidance documents on biosimilar and interchangeable products, select Biosimilars in the topic field. Additional guidance documents that are applicable to biological products, including biosimilar and interchangeable products can be found in other topic areas, such as Chemistry, Manufacturing and Controls (CMC), and Administrative/Procedural.
The Questions and Answers draft and final guidance documents provide answers to common questions on a variety of topics about biosimilars and interchangeable biosimilars. Refer to the table of contents for topics covered in each of the following documents:
- Final guidance: Questions and Answers on Biosimilar Development and the BPCI Act
- Draft guidances: New and Revised Draft Q&As on Biosimilar Development and the BPCI Act and Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act
The Biosimilars Action Plan outlines FDA’s strategy for encouraging the development of safe and effective biosimilar and interchangeable products as potentially lower-cost alternatives to original biologics.
Biosimilars Action Plan
FDA’s Biosimilars Action Plan (BAP) provides information on key actions the Agency is taking to encourage innovation and competition in the market for biologics and to facilitate the development of biosimilars. The BAP builds on the Agency’s progress in implementing the approval pathways for biosimilar and interchangeable products.
Biosimilars can provide more treatment options and potentially reduce costs for patients.
Biosimilar User Fees
FDA is authorized to assess and collect fees for biosimilar biological products under the Biosimilar User Fee Amendments, or BsUFA. FDA dedicates these fees to expedite the review process for biosimilar and interchangeable products, facilitating the development of safe and effective biosimilar products for the American public. FDA prepares annual performance reports and provides a concise and visual presentation of the performance report data in an interactive dashboard.
Office of Therapeutic Biologics and Biosimilars
FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB) supports the development and approval of safe and effective biosimilar and interchangeable products. As part of its mission, OTBB:
- Provides expertise and leadership on biosimilar and interchangeable products for internal and external stakeholders
- Coordinates and supports all biosimilar and interchangeable product activities in the Center for Drug Evaluation and Research (CDER)
- Provides infrastructure and specialized resources to enhance the BsUFA program and support the objectives outlined in the BAP
FY 2021 BsUFA Performance Report
The FY 2021 Performance Report to Congress for the Biosimilar User Fee Act details FDA’s preliminary performance results for 2021 and finalizes FDA’s performance results for 2020.
Congressional Testimony and Legislation
FDA’s Office of Legislation ensures that Congress has accurate and up-to-date information about biomedical research. FDA officials have testified before House and Senate committees and subcommittees to advance legislation that supports the development of biological products, including biosimilar and interchangeable products, and the BsUFA program.
- Congressional Testimony: FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics
- Congressional Testimony: Generic Drug User Fee Act Reauthorization (GDUFA II), Biosimilar User Fee Act Reauthorization (BsUFA II)
- Congressional Testimony: Biosimilars Implementation
- Senate Testimony: Biosimilars Implementation: A Progress Report from FDA
- Sections 7001-7003 (Biologics Price Competition and Innovation Act of 2009) of the Patient Protection and Affordable Care Act (Public Law No. 111-148)
- Advancing Education on Biosimilars Act of 2021
The FDA Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) program offers information on drug development and regulations using a variety of multimedia learning resources. The CDER SBIA Learn web page has many helpful courses and recordings. CDERLearn also offers training and educational resources on a variety of topics.
- If you have a general question about biosimilars and interchangeable products, please email firstname.lastname@example.org.
- If you have a question regarding a product development program or 351(k) BLA for which you are the sponsor, applicant, or authorized representative, please contact the regulatory project manager assigned to the application.