Search Results - "Ebbers, Hans"

Are we ready to close the discussion on the interchangeability of biosimilars? by Ebbers, Hans C., Schellekens, Huub

“…•There are different regulatory approaches toward interchanging biosimilars.•Blinded clinical studies do not reflect switching in clinical practice.•Current…”
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The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review by Barbier, Liese, Ebbers, Hans C., Declerck, Paul, Simoens, Steven, Vulto, Arnold G., Huys, Isabelle

“…To date, no consensus exists among stakeholders about switching patients between reference biological products (RPs) and biosimilars, which may have been…”
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A Retrospective Analysis of the Potential Impact of Differences in Aggregates on Clinical Immunogenicity of Biosimilars and their Reference Products by Fernandez‐Mendivil, Cristina, Kinsella, Niamh M., Ebbers, Hans C.

“…Aggregates, in particular high molecular weight species (HMWs), have been linked to increased immunogenicity. The current understanding on the impact of HMWs…”
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The safety of switching between therapeutic proteins by Ebbers, Hans C, Muenzberg, Michael, Schellekens, Huub

“…The approval of several biosimilars in the past years has prompted discussion on potential safety risks associated with switching to and from these products…”
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Biosimilars: In support of extrapolation of indications by Ebbers, Hans C.

“…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…”
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Interchangeability, immunogenicity and biosimilars by Ebbers, Hans C, Crow, Stacy A, Vulto, Arnold G, Schellekens, Huub

“…For authorized biosimilars to achieve full acceptance in the marketplace, it is crucial that they are considered to be therapeutically equivalent and…”
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Current evidence on the use of the adalimumab biosimilar SB5 (Imraldi TM ): a multidisciplinary perspective by Gisbert, Javier P, Gaffney, Karl, Young, David, Ebbers, Hans C, Girolomoni, Giampiero

“…This review provides an overview of data from trials and real-world studies available for SB5 (Imraldi ) across three main therapeutic areas: rheumatology,…”
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Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab by Liu, Yujie, Xie, Jianhua, Li, Zhuxiang, Mei, Xiong, Cao, Di, Li, Shengfeng, Engle, Linda, Liu, Suli, Ebbers, Hans C., Liu, Cuihua

“…Background and Objective Tocilizumab is an immunoglobulin G1 monoclonal antibody targeting the interleukin-6 receptor (IL-6R). BAT1806/BIIB800…”
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Correction to: Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab by Liu, Yujie, Xie, Jianhua, Li, Zhuxiang, Mei, Xiong, Cao, Di, Li, Shengfeng, Engle, Linda, Liu, Suli, Ebbers, Hans C., Liu, Cuihua

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Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices by Ebbers, Hans C., Chamberlain, Paul

“…The principles of establishing biosimilarity are to demonstrate structural and functional similarity to a reference product using the most discriminatory…”
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Scent dog identification of SARS-CoV-2 infections in different body fluids by Jendrny, Paula, Twele, Friederike, Meller, Sebastian, Schulz, Claudia, von Köckritz-Blickwede, Maren, Osterhaus, Albertus Dominicus Marcellinus Eras, Ebbers, Hans, Ebbers, Janek, Pilchová, Veronika, Pink, Isabell, Welte, Tobias, Manns, Michael Peter, Fathi, Anahita, Addo, Marylyn Martina, Ernst, Christiane, Schäfer, Wencke, Engels, Michael, Petrov, Anja, Marquart, Katharina, Schotte, Ulrich, Schalke, Esther, Volk, Holger Andreas

“…The main strategy to contain the current SARS-CoV-2 pandemic remains to implement a comprehensive testing, tracing and quarantining strategy until vaccination…”
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Real-World Evidence on Etanercept Biosimilar SB4 in Etanercept-Naïve or Switching Patients: A Systematic Review by Ebbers, Hans C., Pieper, Burkhard, Issa, Amine, Addison, Janet, Freudensprung, Ulrich, Rezk, Mourad F.

“…Introduction In 2016, SB4 (Benepali ® ) became the first etanercept (ETN) biosimilar to obtain marketing authorisation in Europe. Despite robust analytical and…”
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An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review by Hariprasad, Seenu M., Gale, Richard P., Weng, Christina Y., Ebbers, Hans C., Rezk, Mourad F., Tadayoni, Ramin

“…Biological therapies have revolutionized the treatment of disease across a number of therapeutic areas including retinal diseases. However, on occasion, such…”
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Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: new insights by Macdougall, Iain C, Roger, Simon D, de Francisco, Angel, Goldsmith, David J A, Schellekens, Huub, Ebbers, Hans, Jelkmann, Wolfgang, London, Gérard, Casadevall, Nicole, Hörl, Walter H, Kemeny, David M, Pollock, Carol

“…Antibody-mediated pure red cell aplasia is a very rare but devastating condition affecting patients receiving treatment with erythropoiesis-stimulating agents…”
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Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars by Ebbers, Hans C., Fehrmann, Bjørn, Ottosen, Mette, Hvorslev, Niels, Høier, Pia, Hwang, Jae-Woong, Chung, Jinhan, Lim, Hyoung Taek, Lee, Shinjung, Hong, Juyoung, Rezk, Mourad Farouk

“…Background Biosimilars must meet stringent regulatory requirements, both at the time of authorization and during their lifecycle. Yet it has been suggested…”
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Contribution of animal studies to evaluate the similarity of biosimilars to reference products by van Meer, Peter J.K., Ebbers, Hans C., Kooijman, Marlous, Gispen-de Wied, Christine C., Silva-Lima, Beatriz, Moors, Ellen H.M., Schellekens, Huub

“…•Animal studies are recommended in EU overarching guidelines to establish biosimilarity.•Animal studies support similarity despite known quality…”
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Characteristics of product recalls of biopharmaceuticals and small-molecule drugs in the USA by Ebbers, Hans C., Tienda, Nina Fuentes de, Hoefnagel, Marcel C., Nibbeling, Ria, Mantel-Teeuwisse, Aukje K.

“…•We identified 1792 recalled products during the study period; 41 recalls occurred for biopharmaceuticals and 1751 for small molecules.•Recalls that concern…”
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Effective pharmaceutical regulation needs alignment with doctors by Ebbers, Hans C., Pieters, Toine, Leufkens, Hubert G., Schellekens, Huub

“…Concerns emanating from the medical community about the safety and efficacy of biosimilars indicate an increasing distrust of the outcome of the drug…”
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Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab by Ebbers, Hans C., van Meer, Peter J.K., Moors, Ellen H.M., Mantel-Teeuwisse, Aukje K., Leufkens, Hubert G.M., Schellekens, Huub

“…•Challenges remain in establishing biosimilarity of anticancer agents.•Preclinical studies can be sensitive but can lack clinical relevance.•It is not…”
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Detection of Post-COVID-19 Patients Using Medical Scent Detection Dogs—A Pilot Study by Twele, Friederike, ten Hagen, Nele Alexandra, Meller, Sebastian, Schulz, Claudia, Osterhaus, Albert, Jendrny, Paula, Ebbers, Hans, Pink, Isabell, Drick, Nora, Welte, Tobias, Schalke, Esther, Volk, Holger Andreas

“…There is a growing number of COVID-19 patients experiencing long-term symptoms months after their acute SARS-CoV-2 infection. Previous research proved dogs'…”
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