Boston Professional Events List

Regulatory Guidance Overview on Labeling for Biosimilar Productions

Mar 25, 2019 - 01:00 PM - 02:30 PM
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

ZIP: 33021
Phone: 844-267-7299 | 954-947-5671  

Prescription drug product labeling communicates the product’s safety and effectiveness information to health care providers. Labeling summarizes the key scientific information that health care providers need to assess if the product is appropriate for use by their patient.
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), are designed to ensure that health care providers have clear and concise information in prescription drug labeling, and to make it easier for health care providers to use labeling to make their prescribing decisions.

Session Highlights
This course will provide an overview of the guidance for labeling Biosimilar products.
This guidance is intended to help applicants develop draft labeling for proposed biosimilar products for submission in a regulatory application.
Topic 1: CFR Review
  • Patient Labeling: 21 CFR 208
  • Revising Biosimilar Product labeling: 21 CFR 601.12
Topic 2: Biosimilar labeling specifics
  • Labeling includes three sections:
    • Highlights of Prescribing Information
    • Table of Contents
    • Full Prescribing Information.
Topic 3: 2017 FDA Final Guidance for Labeling Biosimilar Products
o One of the first items health care professionals may notice in the Highlights section is the addition of a “Biosimilarity Statement” describing the biosimilar product’s relationship to its reference product.
o Understand utilizing the FDA-approved labeling for the reference product for Biosimilar product relevant data and information.
o Discuss the regulations for a biosimilar product not requiring the same labeling as its reference product, biosimilar product labeling may differ from the reference product labeling for a variety of reasons.

Who will benefit
  • Quality Assurance
  • Regulatory Affairs

Speaker Details

Instructor Profile

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. 

Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
Don't wait. Register TODAY or  Email  US [email protected]  

Event Categories
Keywords: pharmaceutical


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