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

• In: Poster presentation
• At: Seoul (South Korea) (2017)
• Type: Poster
• Poster code: POS-RSC-002
• 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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