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  8. Industry Information and Guidance
  1. Biosimilars

Industry Information and Guidance

Biological products are the fastest growing class of therapeutic products in the United States and account for a substantial and increasing portion of health care costs. Congress, through the Biologics Price Competition and Innovation Act (BPCI) of 2009, created an abbreviated approval pathway as a way to provide the public with greater access to biological products that are effective and safe. This pathway was established as a way to provide more treatment options by increasing access to lifesaving medications and potentially lowering health care costs through competition.

Guidance for Industry

FDA provides ongoing guidance about demonstrating biosimilarity and interchangeability through publishing guidance documents (search Biosimilars).

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Biosimilar User Fees

The Federal Food, Drug, and Cosmetic Act, as amended by the Biosimilar User Fee Act of 2017 (BsUFA II), authorizes FDA to assess and collect fees for biosimilar biological products from October 2017 through September 2022. FDA dedicates these fees to expediting the review process for biosimilar biological products. Biosimilar biological products represent an important public health benefit, with the potential to offer lifesaving or life-altering benefits at reduced cost to the patient. BsUFA facilitates the development of safe and effective biosimilar products for the American public.

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Biosimilars Action Plan

The FDA has released the Biosimilars Action Plan (BAP) to provide information about the key actions the agency is taking to encourage innovation and competition among biologics and the development of biosimilars. The BAP builds on the Agency’s progress in implementing the approval pathway for biosimilar and interchangeable products.

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Educational Resources

The FDA Center for Drug Evaluation and Research (CDER) Small Business & Industry Assistance (SBIA) program offers a variety of multimedia learning resources. The CDER SBIA Learn web page has many helpful courses and recording. FDA also has materials for health care professionals on this website under Patient and Prescriber Outreach Materials.

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If you have specific questions regarding the development of a biosimilar or interchangeable product not yet submitted in a 351(k) BLA (marketing application), please contact the Therapeutic Biologics and Biosimilars Staff at ONDTherapeuticBiologicsandBiosimilarsPMStaff@fda.hhs.gov.

If you have a general question about biosimilar 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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Learn More

Implementation of the Biologics Price Competition and Innovation Act of 2009
Overview of the BPCI Act and the Biosimilar Implementation Committee, a cross-center group led by Drs. Janet Woodcock and Karen Midthun. 

Congressional Testimony: Biosimilars Implementation
Congressional testimony from Dr. Janet Woodcock discussing FDA’s implementation of the BPCI Act. 

Senate Testimony: Biosimilar Implementation: A Progress Report from FDA
Senate testimony from Dr. Janet Woodcock discussing FDA’s implementation of the BPCI Act.

Congressional Testimony: Generic Drug User Fee Act Reauthorization (GDUFA II), Biosimilar User Fee Act Reauthorization (BsUFA II)
Congressional testimony from Dr. Janet Woodcock discussing the first reauthorization of GDUFA II, as well as the first reauthorization of BsUFA II. 

Sections 7001-7003 (Biologics Price Competition and Innovation Act of 2009) of the Patient Protection and Affordable Care Act (Public Law No. 111-148)
Official language of the BPCI Act.

From our perspective: Biosimilar product labeling
Blog by Dr. Leah Christl discussing FDA’s approach to biosimilar product labeling.


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