Please use this identifier to cite or link to this item: https://www.um.edu.mt/library/oar/handle/123456789/50901
Title: Biosimilars : drug substance quality issues and their impact on the safety profile of biologics
Authors: Cilia, Mark
Serracino-Inglott, Anthony
Wirth, Francesca
Borg, John-Joseph
Keywords: Biosimilar pharmaceuticals -- Standards
Biosimilar pharmaceuticals -- European Union countries
Biologicals -- Safety measures
Pharmaceutical biotechnology
Issue Date: 2017-09
Publisher: University of Malta. Department of Pharmacy
Citation: Cilia, M., Serracino-Inglott, A., Wirth, F., & Borg, J. J. (2017, September). Biosimilars: drug substance quality issues and their impact on the safety profile of biologics. Poster session presented at the 77th FIP Annual Conference, Seoul, Republic of Korea.
Abstract: A poster presentation regarding biosimilars, drug substance quality issues and their impact on the safety profile of biologics. Introduction: Patent expiry of biologics heralded a new category of medicinal products 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. Aims: • To identify and analyse quality issues encountered during development and manufacture of biosimilars’ drug substance; • To determine whether the advent of biosimilars in the EU changed the safety landscape of biologics.
URI: https://www.um.edu.mt/library/oar/handle/123456789/50901
Appears in Collections:Scholarly Works - FacM&SPha



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