Thijs J. Giezen
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View article: Intranasal vitamin B<sub>12</sub> administration in elderly patients: A randomized controlled comparison of two dosage regimens
Intranasal vitamin B<sub>12</sub> administration in elderly patients: A randomized controlled comparison of two dosage regimens Open
Aim Vitamin B 12 deficiency is common in the elderly population. Standard treatment via intramuscular injections, however, has several disadvantages. Safer and more convenient dosage forms such as intranasal are therefore being explored. T…
View article: Post-approval quality-related regulatory actions for biopharmaceuticals approved in the European Union and the United States between 1995 and 2019
Post-approval quality-related regulatory actions for biopharmaceuticals approved in the European Union and the United States between 1995 and 2019 Open
The quality of biopharmaceuticals is carefully monitored by manufacturers and regulators to ensure safety and efficacy throughout the entire product life cycle. Quality defects can lead to post-approval regulatory actions (RAs) to inform h…
View article: Recommendations on TNFα inhibitor biosimilar use in clinical practice: a comparison of European gastroenterology IBD guidance
Recommendations on TNFα inhibitor biosimilar use in clinical practice: a comparison of European gastroenterology IBD guidance Open
The majority of gastroenterology associations endorsed biosimilar use. The lack of (up-to-date) guidelines for some associations indicates an area of improvement to support biosimilar use in clinical practice.
View article: Discontinuation of infliximab treatment in patients with inflammatory bowel disease who retransitioned to originator and those who remained on biosimilar
Discontinuation of infliximab treatment in patients with inflammatory bowel disease who retransitioned to originator and those who remained on biosimilar Open
Background: Many patients with inflammatory bowel disease (IBD) have transitioned from an infliximab originator to a biosimilar. However, some patients retransition to the originator (i.e. stop biosimilar and reinitiate the originator). Wh…
View article: Nature and timing of post-approval manufacturing changes of tumour necrosis factor α inhibitor products: A 20-year follow-up study of originators and biosimilars
Nature and timing of post-approval manufacturing changes of tumour necrosis factor α inhibitor products: A 20-year follow-up study of originators and biosimilars Open
The manufacturing of biopharmaceuticals is complex, and minor changes in the process may affect quality attributes (QAs) that may, in turn, impact clinical outcomes. Regulatory documents from the European Medicines Agency were used to char…
View article: P683 Discontinuation of infliximab treatment: a comparison between IBD patients who retransitioned to originator and those who remained on biosimilar
P683 Discontinuation of infliximab treatment: a comparison between IBD patients who retransitioned to originator and those who remained on biosimilar Open
Background Since the introduction of infliximab biosimilars, many patients with inflammatory bowel disease (IBD) transitioned from originator (Remicade) to an infliximab biosimilar, mainly for cost containment. Studies showed that, despite…
View article: Patients Retransitioning from Biosimilar TNFα Inhibitor to the Corresponding Originator After Initial Transitioning to the Biosimilar: A Systematic Review
Patients Retransitioning from Biosimilar TNFα Inhibitor to the Corresponding Originator After Initial Transitioning to the Biosimilar: A Systematic Review Open
In studies on transitioning patients from TNFα originator to biosimilar, 8% of patients retransitioned. Retransitioning appeared to be lower in studies that included only patients with stable disease and in studies that did not offer patie…
View article: Incidence of and Reasons and Determinants Associated with Retransitioning from Biosimilar Etanercept to Originator Etanercept
Incidence of and Reasons and Determinants Associated with Retransitioning from Biosimilar Etanercept to Originator Etanercept Open
View article: Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions
Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions Open
The relevance of biological therapies for an increasing number of conditions is on the rise. Following the expiry of the initial period of market exclusivity, many of these successful therapies have seen the arrival of biosimilars on the m…
View article: Switching TNFα inhibitors: Patterns and determinants
Switching TNFα inhibitors: Patterns and determinants Open
The aim of this study was to assess switching patterns and determinants for switching in patients initiating TNFα inhibitor (TNFα‐i) treatment. Patients were included who started TNFα‐i treatment between July 1, 2012 and December 31, 2017,…
View article: Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars
Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars Open
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 exis…
View article: QTc Prolongation in COVID-19 Patients Using Chloroquine
QTc Prolongation in COVID-19 Patients Using Chloroquine Open
View article: Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study
Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study Open
View article: Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF‐α Inhibitors
Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF‐α Inhibitors Open
The summary of product characteristics (SmPCs) is an important information source that includes the adverse drug reactions (ADRs) associated with the drug. Drugs with the same mechanism of action are expected to have a similar ADR profile …
View article: Hoe bereikt een nieuw geneesmiddel de patiënt
Hoe bereikt een nieuw geneesmiddel de patiënt Open
The Medicines Evaluation Board (MEB) grants market authorisation for medicinal products in the Netherlands. The European Medicines Agency (EMA) coordinates the evaluation and safeguarding of medicinal products in the European Union. The co…
View article: Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review
Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review Open
View article: Drug-drug interactions with metronidazole and itraconazole in patients using acenocoumarol
Drug-drug interactions with metronidazole and itraconazole in patients using acenocoumarol Open
View article: Adverse events related to biologicals used for patients with multiple sclerosis: a comparison between information originating from regulators and information originating from the scientific community
Adverse events related to biologicals used for patients with multiple sclerosis: a comparison between information originating from regulators and information originating from the scientific community Open
Background and purpose Clinical decision making is facilitated by healthcare professionals’ and patients’ adequate knowledge of the adverse events. This is especially important for biologicals used for treating multiple sclerosis (MS). So …
View article: Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study
Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study Open
View article: Post‐marketing dosing changes in the label of biologicals
Post‐marketing dosing changes in the label of biologicals Open
Aim The aim of this study was to evaluate post‐marketing label changes in dosing information of biologicals. Methods Biologicals authorized between 2007 and 2014 by the European Medicines Agency (EMA) were included and followed up from mar…
View article: Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice
Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice Open
Biologicals are established treatment options that require pharmacovigilance adapted to their specific nature, including the need for products to be identifiable up to the specific manufacturer in reports of adverse drug reactions ( ADR s)…
View article: Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016
Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016 Open
Introduction: Biological drugs are improving therapeutic options for many diseases, but access to these therapies is being held back by costs.Biosimilars off er a lower-cost alternative to the corresponding original therapeutic protein, th…