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Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: new insights.
Antibody-mediated pure red cell aplasia is a very rare but devastating condition affecting patients receiving treatment with erythropoiesis-stimulating agents. New cases continue to emerge, generally… Expand
The safety of switching between therapeutic proteins
Introduction: The approval of several biosimilars in the past years has prompted discussion on potential safety risks associated with switching to and from these products. It has been suggested that… Expand
Interchangeability, immunogenicity and biosimilars
For authorized biosimilars to achieve full acceptance in the marketplace, it is crucial that they are considered to be therapeutically equivalent and interchangeable with the brand reference product.
Contribution of animal studies to evaluate the similarity of biosimilars to reference products.
The European Union (EU) was the first region to establish a regulatory framework for biosimilars, in which animal studies are required to confirm similarity to a reference product. However, animal… Expand
Biosimilars: in support of extrapolation of indications.
- H. Ebbers
- Journal of Crohn's & colitis
- 1 May 2014
Biosimilars have the potential to lead to enormous cost savings in healthcare without reducing the level of care for patients. In Europe, biosimilars have to demonstrate comparability in an extensive… Expand
Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices
The principles of establishing biosimilarity are to demonstrate structural and functional similarity to a reference product using the most discriminatory analytical methods. There is still… Expand
The Cost‐Effectiveness of Periodic Safety Update Reports for Biologicals in Europe
- J. Bouvy, H. Ebbers, H. Schellekens, M. A. Koopmanschap
- Clinical pharmacology and therapeutics
- 1 May 2013
We analyzed the cost‐effectiveness of all Periodic Safety Update Reports (PSURs) submitted for biologicals in Europe from 1995 to 2009 by comparing two regulatory scenarios: full regulation (PSUR… Expand
The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals: a simulation study.
- N. Vermeer, H. Ebbers, S. Straus, H. Leufkens, T. Egberts, M. D. De Bruin
- Pharmacoepidemiology and drug safety
- 1 March 2016
BACKGROUND AND OBJECTIVE The availability of accurate product-specific exposure information is essential in the pharmacovigilance of biologicals, because differences in the safety profile may emerge… Expand
Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab.
- H. Ebbers, P. V. van Meer, E. Moors, A. Mantel-Teeuwisse, H. Leufkens, H. Schellekens
- Drug discovery today
- 1 September 2013
Biosimilars have been available on the European market since 2006 and experience with their use is increasing. The next wave of biopharmaceuticals that are about to lose patent protection consists of… Expand
The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals
- H. Ebbers, A. Mantel-Teeuwisse, F. Sayed-Tabatabaei, E. Moors, H. Schellekens, H. Leufkens
- European Journal of Clinical Pharmacology
- 17 June 2012
PurposeTo describe and assess the outcomes of Periodic Safety Update Report (PSUR) evaluations of biopharmaceuticals.MethodsA cross-sectional analysis was performed of follow-up requirements of PSURs… Expand