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  8. Industry Information and Guidance
  1. Biosimilars

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

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:

The Biosimilars Action Plan

Efficiency, Clarity, Communication, Competition

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

Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products

FDA has released its updated labeling guidance for biosimilar and interchangeable biosimilar products to include a “biosimilarity statement.” Learn more about this update from Sarah Yim, M.D., Director of the Office of New Drugs’ 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:

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.

FY 2021 BsUFA Performance Report

The FY 2022 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 2021.



Educational Resources

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.

Contact Us

  • If you have a general question about biosimilars and interchangeable products, please email druginfo@fda.hhs.gov.
  • 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.
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