Search results for: Huub Schellekens

Items from 1 to 20 out of 52 results

article

Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product

Liem Andhyk Halim, Maripaz Márquez, Roel F. Maas-Bakker, Gilberto Castañeda-Hernández, more

Pharmaceutical Research > 2018 > 35 > 11 > 1-12

Purpose Filgrastim, a recombinant human granulocyte-colony stimulating factor, is widely used to treat congenital and acquired neutropenia. Following patent expiration of the innovator filgrastim product, biosimilar filgrastim products have been approved in the EU and shown to be comparable with the innovator with respect to quality, safety and efficacy. In less regulated markets, copy filgrastim...

article

How institutional logics hamper innovation: The case of animal testing

Marlous Kooijman, Marko P. Hekkert, Peter J.K. van Meer, Ellen H.M. Moors, more

Technological Forecasting and Social Change > 2017 > 118 > C > 70-79

For radical innovation to become successful the substitution of established practices are essential. Nevertheless, in the innovation literature novelty is often at the center and only little attention is paid to the influence of established technologies and underlying routines. This paper aims to contribute to this gap by increasing the understanding about the effect of persistence of established...

article

Iron nanomedicines induce Toll-like receptor activation, cytokine production and complement activation

Johan J.F. Verhoef, A. Marit de Groot, Marc van Moorsel, Jeffrey Ritsema, more

Biomaterials > 2017 > 119 > C > 68-77

Approximately a dozen of intravenous iron nanomedicines gained marketing authorization in the last two decades. These products are generally considered as safe, but have been associated with an increased risk for hypersensitivity-like reactions of which the underlying mechanisms are unknown. We hypothesized that iron nanomedicines can trigger the innate immune system. We hereto investigated the physico-chemical...

article

Safety and efficacy of biosimilars in oncology

Huub Schellekens, Josef S Smolen, Mario Dicato, Robert M Rifkin

The Lancet Oncology > 2016 > 17 > 11 > e502-e509

Biosimilars are considered to be one of the solutions to combat the substantially increasing costs of cancer treatment, and its imminent introduction is expected to expand affordability worldwide. However, biosimilar monoclonal antibodies provide many challenges compared with first-generation biosimilars, growth factors, and hormones, because they have shown only a modest clinical effect, and are...

article

A novel oral iron-complex formulation: Encapsulation of hemin in polymeric micelles and its in vitro absorption

Kimberley Span, Johan J.F. Verhoef, Hedi Hunt, Cornelus F. van Nostrum, more

European Journal of Pharmaceutics and Biopharmaceutics > 2016 > 108 > C > 226-234

Anemia resulting from iron deficiency is one of the most prevalent diseases in the world. As iron has important roles in several biological processes such as oxygen transport, DNA synthesis and cell growth, there is a high need for iron therapies that result in high iron bioavailability with minimal toxic effects to treat patients suffering from anemia. This study aims to develop a novel oral iron-complex...

chapter

Biosimilar epoetins

Huub Schellekens

Milestones in Drug Therapy > Erythropoietins, Erythropoietic Factors, and Erythropoiesis > Erythropoiesis-stimulating agents > 105-114

Recombinant DNA technology and hybridoma techniques enabled the development of therapeutic proteins such as the interferons (IFN), erythropoietin (EPO), insulin, growth hormones, cytokines, and monoclonal antibodies [1]. These proteins have revolutionised the treatment of many diseases, including, cancer, hepatitis, and multiple sclerosis. The patents of the first generation of biopharmaceuticals...

article

Contribution of animal studies to evaluate the similarity of biosimilars to reference products

Peter J.K. van Meer, Hans C. Ebbers, Marlous Kooijman, Christine C. Gispen-de Wied, more

Drug Discovery Today > 2015 > 20 > 4 > 483-490

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 studies described in European public assessment reports (EPARs) or marketing authorization applications (MAAs) did not identify clinically or toxicologically relevant differences despite differences in quality,...

article

Development of ADA Against Recombinant Human Interferon Beta in Immune Tolerant Mice Requires Rapid Recruitment of CD4⁺ T Cells, Induces Formation of Germinal Centers but Lacks Susceptibility for (Most) Adjuvants

Grzegorz Kijanka, Melody Sauerborn, Louis Boon, Huub Schellekens, more

Journal of Pharmaceutical Sciences > 104 > 2 > 396 - 406

Immunological processes leading to formation of antidrug antibodies (Abs) against recombinant human proteins remain poorly understood. Animal and clinical studies revealed that immunogenicity shares both T‐cell‐dependent (requirement of CD4⁺ T cells, isotype switching) and T‐cell‐independent (involvement of Marginal Zone B cells, apparent lack of memory) characteristics. We used immune tolerant mice...

article

Towards a sustainable system of drug development

Ellen H.M. Moors, Adam F. Cohen, Huub Schellekens

Drug Discovery Today > 2014 > 19 > 11 > 1711-1720

Drug development has become the exclusive activity of large pharmaceutical companies. However, the output of new drugs has been decreasing for the past decade and the prices of new drugs have risen steadily, leading to access problems for many patients. By analyzing the history of drug development and the pharmaceutical industry, we identified the main factors causing this system failure. Although...

article

Development of a Transgenic Mouse Model to Study the Immunogenicity of Recombinant Human Insulin

Riccardo Torosantucci, Vera Brinks, Grzegorz Kijanka, Liem Andhyk Halim, more

Journal of Pharmaceutical Sciences > 103 > 5 > 1367 - 1374

Mouse models are commonly used to assess the immunogenicity of therapeutic proteins and to investigate the immunological processes leading to antidrug antibodies. The aim of this work was to develop a transgenic (TG) Balb/c mouse model for evaluating the immunogenicity of recombinant human insulin (insulin) formulations. Validation of the model was performed by measuring the antibody response against...

article

How Bio-questionable are the Different Recombinant Human Erythropoietin Copy Products in Thailand?

Liem Andhyk Halim, Vera Brinks, Wim Jiskoot, Stefan Romeijn, more

Pharmaceutical Research > 2014 > 31 > 5 > 1210-1218

Purpose The high prevalence of pure red cell aplasia in Thailand has been associated with the sharp increase in number of recombinant human erythropoietin (rhEPO) copy products, based on a classical generic regulatory pathway, which have entered the market. This study aims to assess the quality of rhEPO copy products being used in Thailand. Methods Twelve rhEPO copy products were purchased from...

article

Effect of Arginine on Pre-nucleus Stage of Interferon Beta-1b Aggregation

Ahmad Fazeli, Mohadeseh Haji-Abdolvahab, Seyed Abbas Shojaosadati, Huub Schellekens, more

AAPS PharmSciTech > 2014 > 15 > 6 > 1619-1629

Understanding the mechanism of aggregation of a therapeutic protein would not only ease the manufacturing processing but could also lead to a more stable finished product. Aggregation of recombinant interferon (IFNβ-1b) was studied by heating, oxidizing, or seeding of unformulated monomeric solution. The formation of aggregates was monitored by dynamic light scattering (DLS) and UV spectroscopy. The...

article

Different Pharmaceutical Products Need Similar Terminology

Daan J. A. Crommelin, Jon S. B. Vlieger, Vera Weinstein, Stefan Mühlebach, more

The AAPS Journal > 2014 > 16 > 1 > 11-14

In the last decade, discussions on the development of the regulatory framework of generic versions of complex drugs such as biologicals and non-biological complex drugs have attracted broad attention. The terminology used is far from harmonized and can lead to multiple interpretations of legal texts, reflection papers, and guidance documents regarding market introduction as well as reimbursement....

article

How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider

Huub Schellekens, Sven Stegemann, Vera Weinstein, Jon S. B. Vlieger, more

The AAPS Journal > 2014 > 16 > 1 > 15-21

The aim of this critical review is to reach a global consensus regarding the introduction of follow-on versions of nonbiological complex drugs (NBCD). A nonbiological complex drug is a medicinal product, not being a biological medicine, where the active substance is not a homo-molecular structure, but consists of different (closely related and often nanoparticulate) structures that cannot be isolated...

article

Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab

Hans C. Ebbers, Peter J.K. van Meer, Ellen H.M. Moors, Aukje K. Mantel-Teeuwisse, more

Drug Discovery Today > 2013 > 18 > 17-18 > 872-879

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 more-complicated products, including many monoclonal antibodies. Guidance has been released on the particulars of a biosimilarity exercise involving these products. Considerable challenges exist to establish...

article

Differences Between Post-Authorization Adverse Drug Reactions of Biopharmaceuticals and Small Molecules

Hans C. Ebbers, Esraa Al-Temimi, Ellen H. M. Moors, Aukje K. Mantel-Teeuwisse, more

BioDrugs > 2013 > 27 > 2 > 167-174

Background The nature of adverse drug reactions observed post-authorization for biopharmaceuticals differs from that observed for chemically synthesized, small molecules (SMs). However, it remains unclear how much of the observed differences can be attributed to differences in authorized indications of the two product groups. Objective To investigate if the nature of adverse drug reactions identified...

article

Effect of Treatment Regimen on the Immunogenicity of Human Interferon Beta in Immune Tolerant Mice

Grzegorz Kijanka, Wim Jiskoot, Huub Schellekens, Vera Brinks

Pharmaceutical Research > 2013 > 30 > 6 > 1553-1560

Purpose Interferon beta is commonly used as therapeutic in the first line of therapy for multiple sclerosis. However, depending on the product, it induces an antibody response in up to 60% of patients. This study evaluated the impact of therapy related factors like dose, route of administration and administration frequency on the immunogenicity of one of the originator interferon beta drugs (Betaferon®)...

article

The Immunogenicity of Polyethylene Glycol: Facts and Fiction

Huub Schellekens, Wim E. Hennink, Vera Brinks

Pharmaceutical Research > 2013 > 30 > 7 > 1729-1734

An increasing number of pegylated therapeutic proteins and drug targeting compounds are being introduced in the clinic. Pegylation is intended to increase circulation time and to reduce an immunogenic response. Recently however a number of publications have appeared claiming that the polyethylene glycol (PEG) moiety of these products in itself may be immunogenic and that the induced anti-PEG antibodies...

article

The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals

Hans C. Ebbers, Aukje K. Mantel-Teeuwisse, Fakhredin A. Sayed-Tabatabaei, Ellen H. M. Moors, more

European Journal of Clinical Pharmacology > 2013 > 69 > 2 > 217-226

Purpose To describe and assess the outcomes of Periodic Safety Update Report (PSUR) evaluations of biopharmaceuticals. Methods A cross-sectional analysis was performed of follow-up requirements of PSURs submitted for centrally approved biopharmaceuticals in the European Union between 1 July 2008 and 30 June 2010. A follow-up analysis on a subset of products that submitted multiple PSURs within the...

article

Antibody Response Against Betaferon® in Immune Tolerant Mice: Involvement of Marginal Zone B-cells and CD4+ T-cells and Apparent Lack of Immunological Memory

Melody Sauerborn, Miranda M. C. Beers, Wim Jiskoot, Grzegorz M. Kijanka, more

Journal of Clinical Immunology > 2013 > 33 > 1 > 255-263

Purpose The immunological processes underlying immunogenicity of recombinant human therapeutics are poorly understood. Using an immune tolerant mouse model we previously demonstrated that aggregates are a major trigger of the antidrug antibody (ADA) response against recombinant human interferon beta (rhIFNβ) products including Betaferon®, and that immunological memory seems to be lacking after a rechallenge...

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INFONA - science communication portal

Search results for: Huub Schellekens

Quality Comparison of Biosimilar and Copy Filgrastim Products with the Innovator Product

How institutional logics hamper innovation: The case of animal testing

Iron nanomedicines induce Toll-like receptor activation, cytokine production and complement activation

Safety and efficacy of biosimilars in oncology

A novel oral iron-complex formulation: Encapsulation of hemin in polymeric micelles and its in vitro absorption

Biosimilar epoetins

Contribution of animal studies to evaluate the similarity of biosimilars to reference products

Development of ADA Against Recombinant Human Interferon Beta in Immune Tolerant Mice Requires Rapid Recruitment of CD4⁺ T Cells, Induces Formation of Germinal Centers but Lacks Susceptibility for (Most) Adjuvants

Towards a sustainable system of drug development

Development of a Transgenic Mouse Model to Study the Immunogenicity of Recombinant Human Insulin

How Bio-questionable are the Different Recombinant Human Erythropoietin Copy Products in Thailand?

Effect of Arginine on Pre-nucleus Stage of Interferon Beta-1b Aggregation

Different Pharmaceutical Products Need Similar Terminology

How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider

Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab

Differences Between Post-Authorization Adverse Drug Reactions of Biopharmaceuticals and Small Molecules

Effect of Treatment Regimen on the Immunogenicity of Human Interferon Beta in Immune Tolerant Mice

The Immunogenicity of Polyethylene Glycol: Facts and Fiction

The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals

Antibody Response Against Betaferon® in Immune Tolerant Mice: Involvement of Marginal Zone B-cells and CD4+ T-cells and Apparent Lack of Immunological Memory

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