How to Use the FDA’s Final Guidance to Correctly Label Biosimilar Products

  • Product Id : FDB2803
  • Category : , ,
  • Presenter :
  • Scheduled On : January 10 2019 1:00 pm
  • Duration : 90 Minutes

The FDA has finalized its regulations on the content and format of labeling for prescription drug products, including biological products. The final labeling regulations, commonly known as the Physician Labeling Rule (PLR), help ensure that health care providers have clear and concise information in prescription drug labeling, and also make it easier for them to assess if the product is appropriate for use by their patient. If you’re developing draft labeling for biosimilar products for submission in a regulatory application, you need to know about the regulations so that you don’t run into any problems later.

Get up to speed on the latest FDA guidance for labeling biosimilar products. Learn the Code of Federal Regulations (CFR) for patient labeling, and for revising biosimilar product labeling. Understand the labeling specifics relating to all three sections: i.e. highlights of prescribing information, table of contents, and full prescribing information. And learn how to use the FDA’s final guidance to correctly label biosimilar products, and develop draft labeling for biosimilar products to be submitted in a regulatory application.

Session Highlights:

Topic 1: CFR Review

  • Patient Labeling: 21 CFR 208
  • Revising Biosimilar Product labeling: 21 CFR 601.12

Topic 2: Biosimilar labeling specifics

  • Includes the following 3 sections:
    • Highlights of prescribing information
    • Table of contents
    • Full prescribing information

Topic 3: FDA Final Guidance for Labeling Biosimilar Products

  • “Biosimilarity Statement” describing a biosimilar product’s relationship to its reference product
  • How to utilize FDA-approved labeling for the reference product
  • Regulations for a biosimilar products not requiring the same labeling as its reference product
Areas Covered in the Session :

  • Definition of biosimilar products
  • Brief discussion on history of biosimilar product labeling
  • Biosimilar product labeling overview
    • Clinical data
    • Comparative clinical data
    • Naming
    • Licensing
    • Label format & content
  • Review information contained in the FDA’s final guidance on biosimilar labeling
  • Review sections of a biosimilar label
Who Should Attend:

  • Research and Development Departments
  • Quality Departments
  • Regulatory Affairs Departments
  • Compliance Departments
  • All Drugs, Biologics, and Biotech Professionals


Kelly Thomas

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.



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