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U.S. Department of Health and Human Services


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Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009

   PDF Version of this Guidance Document

            Draft Guidance: This guidance document is being distributed for comment purposes only.


Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register 

For questions regarding this draft document contact (CDER) Sandra Benton at 301-796-2500 or (CBER) Office of Communication, Outreach and Development at 1-800-835-4709 or 301-827-1800. 

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)

February 2012

Guidance for Industry on Biosimilars:  Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

Table of Contents











 This guidance provides answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).  The questions and answers (Q&As) are grouped below in the following categories:  

  • Biosimilarity or Interchangeability
  • Provisions Related to Requirement to Submit a BLA for a “Biological Product”
  • Exclusivity

The BPCI Act amends the Public Health Service Act (PHS Act) and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product (see sections 7001 through 7003 of the Patient Protection and Affordable Care Act (Pub. L. 111-148) (Affordable Care Act)).   On November 2 and 3, 2010, FDA held a public hearing and established a public docket to obtain input on specific issues and challenges associated with the implementation of the BPCI Act (see Docket No. FDA-2010-N-0477).  This guidance describes FDA’s current interpretation of certain statutory requirements added by the BPCI Act and reflects consideration of the comments concerning those requirements that were submitted to the public docket. 

This guidance is one in a series of guidances that FDA is developing to implement the BPCI Act.  The guidances address a broad range of issues, including: 

  • Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
  • Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
  • Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

When applicable, references to information in these guidances are included in this Q&A Guidance.

The Q&A format is intended to promote transparency and facilitate development programs for proposed biosimilar products by addressing questions that may arise in the early stages of development.  In addition, these Q&As respond to questions the Agency has received from prospective BLA and new drug application (NDA) applicants regarding the appropriate statutory authority under which certain biological products will be regulated.  FDA intends to update this guidance to include additional Q&As as appropriate.2 

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidances means that something is suggested or recommended, but not required.  


Status of Draft Guidance Q&As for Comment and Final Guidance Q&As

Q&A Category
Q&A Numbers
Publication Date of Draft Guidance Q&As for Comment
Comment Period
Publication Date of Final Guidance Q&As

I.1. - I.15.



II.1. - II.2.



III.1. - III.2.




1.This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA or the Agency). 

Guidance documents are available on the CDER guidance page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. We update guidances periodically. To make sure you have the most recent version of a guidance, check the CDER guidance page.

2. The process by which FDA is requesting public comment on proposed Q&As and issuing new Q&As is described in the accompanying FEDERAL REGISTER notice.