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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 |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| Biosimilars_drug_substance_quality_issues_and_their_impact_on_the_safety_profile_of_biologics_2017.pdf | 627.38 kB | Adobe PDF | View/Open |
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