Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars

Autor: Alsamil, Ali M, Giezen, Thijs J, Egberts, Toine C, Leufkens, Hubert G, Gardarsdottir, Helga, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology

Publikováno v: Pharmaceuticals
Volume 14
Issue 3
Pharmaceuticals, Vol 14, Iss 189, p 189 (2021)
Pharmaceuticals (Basel, Switzerland), 14(3), 1. MDPI AG

Regulatory approval of biosimilars predominantly relies on biosimilarity assessments of quality attributes (QAs), particularly the potentially critical QAs (pCQAs) that may affect the clinical profile. However, a limited understanding exists concerni

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8d9dfa195948044b2dc06552dfd653e5
https://dspace.library.uu.nl/handle/1874/411691

Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study

Autor: Alsamil, Ali M, Giezen, Thijs J, Egberts, Toine C, Leufkens, Hubert G, Gardarsdottir, Helga, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology

Publikováno v: Biologicals, 69, 30. Academic Press Inc.

Biosimilar approval relies on the comparability of quality attributes (QAs), for which information can be derived from regulatory or scientific communities. Limited information is known about whether these sources are consistent with or complementary

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e8be33d1fe2db32844d371b72318409d
https://pubmed.ncbi.nlm.nih.gov/33454195

Improving the Contribution of Regulatory Assessment Reports to Health Technology Assessments—A Collaboration between the European Medicines Agency and the European network for Health Technology Assessment

Autor: Hans-Georg Eichler, Anne Gourvil, Michael Berntgen, Finn Børlum Kristensen, Wim G. Goettsch, Mira Pavlovic

Publikováno v: Value in Health. 17:634-641

In response to a recommendation from the Pharmaceutical Forum, the European Medicines Agency and the European network for Health Technology Assessment initiated a collaboration with the aim to improve the contribution regulatory assessment reports ca

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cd5701b19b4978517031d20e6beb1d4f
https://doi.org/10.1016/j.jval.2014.04.006

Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars.

Autor: Alsamil AM; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Faculty of Science, Utrecht University, 3584 CG Utrecht, The Netherlands.; Pharmaceutical Product Evaluation Directorate, Drug sector, Saudi Food and Drug Authority, Riyadh 13513-7148, Saudi Arabia., Giezen TJ; Foundation Pharmacy for Hospitals in Haarlem, 2035 RC Haarlem, The Netherlands.; Department of Clinical Pharmacy, Spaarne Gasthuis, 2035 RC Haarlem, The Netherlands., Egberts TC; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Faculty of Science, Utrecht University, 3584 CG Utrecht, The Netherlands.; Department of Clinical Pharmacy, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands., Leufkens HG; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Faculty of Science, Utrecht University, 3584 CG Utrecht, The Netherlands., Gardarsdottir H; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Faculty of Science, Utrecht University, 3584 CG Utrecht, The Netherlands.; Department of Clinical Pharmacy, University Medical Center Utrecht, 3584 CX Utrecht, The Netherlands.; Department of Pharmaceutical Sciences, University of Iceland, 107 Reykjavik, Iceland.

Publikováno v: Pharmaceuticals (Basel, Switzerland) [Pharmaceuticals (Basel)] 2021 Feb 25; Vol. 14 (3). Date of Electronic Publication: 2021 Feb 25.