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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
BackgroundPatent 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.
PurposeTo identify and analyse quality issues.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.
Last update 4 October 2019