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Biosimilars: drug substance quality issues and their impact on the safety profile of biologics

  • At: 2017 FIP Congress in Seoul (South Korea)
  • Type: Poster
  • By: CILIA, Mark (University of Malta, Pharmacy, Msida, Malta)
  • Co-author(s): Mark Cilia: Pharmacy, University of Malta, Msida, Malta
    Anthony Serracino-Inglott: Pharmacy, University of Malta, Msida, Malta
    Francesca Wirth: Pharmacy, University of Malta, Msida, Malta
    John-Joseph Borg: Post Licensing, Medicines Authority, San Gwann, Malta
  • Abstract:

    Background

    Patent expiry of biologics heralded a new category of medicinals known as biosimilars, approved on the basis of similarity to their reference products. However, concerns exist among healthcare professionals about the quality and safety of biosimilars compared to their reference products.

    Purpose

    To identify and analyse quality issues..

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Last update 4 October 2019

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