Biosimilarity assessment of quality attributes in European public assessment reports of adalimumab biosimilars
Biosimilar regulatory approval fundamentally relies on biosimilarity assessments of quality attributes (QAs). A limited information is known about the QAs that were assessed to establish the biosimilarity and reported in the European public assessment reports (EPARs) that were published by the European Medicine Agency (EMA). We found substantial variability in QAs reporting between the included EPARs of seven adalimumab biosimilars containing the same active substance. Biosimilarity assessment of QAs should be complete and more consistent in EPARs, as these are used by the pharmaceutical industry, healthcare professionals, and other regulators to support their own decision-making processes.
In 2008, Ali Alsamil started his career as a regulator at Saudi FDA after completing a bachelor's degree in biochemistry. After achieving a master’s degree in biomedical science, Ali works as an assessor of biological drugs at Saudi FDA, and as a voluntary government liaison in a committee of biologics monographs at US pharmacopeia. Currently, Ali is a Ph.D. candidate at Utrecht University, where he is conducting research projects that explore the challenges of assessing the biosimilarity of quality attributes (QAs) as these are central in the development and regulatory review of biologicals and biosimilars. The project also focuses on understanding the role of the QAs in biosimilarity demonstration of biosimilars from a quality and regulatory perspective
Bram Klein Wentink
UU, Faculty of Science
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