2018 FDA Final Guidance for Labeling Biosimilar Products

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Fri, Sep 07, 2018
Length
90 minutes
Product Description

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


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 with industry veteran Kelly Thomas 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 Objectives

  • Understand how to properly label a biosimilar product
  • Ensure health care providers have the proper information to accurately determine the correct prescription
  • Limit product liability

Session Highlights

Here’s a taste of what you will uncover:

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:  2018 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

Session Agenda

  • 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

  • Quality assurance personnel
  • Regulatory affairs personnel
  • Drugs, biologics, and biotech professionals
  • Anyone involved with FDA

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Kelly  Thomas

Kelly 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...   More Info
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