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Please use this identifier to cite or link to this item: https://www.um.edu.mt/library/oar/handle/123456789/50901
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dc.date.accessioned2020-01-27T13:47:37Z-
dc.date.available2020-01-27T13:47:37Z-
dc.date.issued2017-09-
dc.identifier.citationCilia, 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.en_GB
dc.identifier.urihttps://www.um.edu.mt/library/oar/handle/123456789/50901-
dc.description.abstractA 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.en_GB
dc.language.isoenen_GB
dc.publisherUniversity of Malta. Department of Pharmacyen_GB
dc.rightsinfo:eu-repo/semantics/openAccessen_GB
dc.subjectBiosimilar pharmaceuticals -- Standardsen_GB
dc.subjectBiosimilar pharmaceuticals -- European Union countriesen_GB
dc.subjectBiologicals -- Safety measuresen_GB
dc.subjectPharmaceutical biotechnologyen_GB
dc.titleBiosimilars : drug substance quality issues and their impact on the safety profile of biologicsen_GB
dc.typepresentationen_GB
dc.rights.holderThe copyright of this work belongs to the author(s)/publisher. The rights of this work are as defined by the appropriate Copyright Legislation or as modified by any successive legislation. Users may access this work and can make use of the information contained in accordance with the Copyright Legislation provided that the author must be properly acknowledged. Further distribution or reproduction in any format is prohibited without the prior permission of the copyright holder.en_GB
dc.description.reviewedN/Aen_GB
dc.contributor.creatorCilia, Mark-
dc.contributor.creatorSerracino-Inglott, Anthony-
dc.contributor.creatorWirth, Francesca-
dc.contributor.creatorBorg, John-Joseph-
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