Journal Article10.1517/14712591003662615
Are biosimilars really generics
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TL;DR: Biosimilars should not be brought to market using the same procedure applied to generics, and existing and future regulation should prevent inappropriate and automatic substitution of a biosimilar for a reference biopharmaceutical product.
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Abstract: Importance of the field: Ever since the formation of the first biotechnology company almost three decades ago, more than 150 biopharmaceutical products have been marketed across the globe. The oldest of these biotechnology-derived products are now at the end of their patent lives, as a result of which, the development of ‘biosimilars’ is increasing.Areas covered in the review: The review highlights aspects in which biosimilars differ from generic drugs.What the reader will gain: The active substance of a biosimilar medicine is similar to the one of the biological reference medicine; however, biosimilars differ from generics of pharmacological drugs in aspects like size and complexity of the active substance, and the nature of the manufacturing process. The manufacture of a biopharmaceutical product is complex and involves several isolation and purification steps. These procedures are proprietary to the manufacturer of the originator product and hence even minor changes in production can have serious impli...
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Citations
Continuous downstream processing of biopharmaceuticals
TL;DR: The problem of 'batch' definition has been solved and paved the way for implementation of continuous downstream processing of biopharmaceuticals from a regulatory viewpoint.
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Recommendations for the regulation of biosimilars and their implementation in Latin America
Valderílio Feijó Azevedo,Eduardo Mysler,Alexis Aceituno Álvarez,Juana Hughes,Francisco Javier Flores-Murrieta,Eva Maria Ruiz de Castilla +5 more
TL;DR: Countries in the region must enhance their pharmacovigilance to include training more regulatory staff, more public and professional awareness on the importance of reporting adverse events and better systems to capture and analyze data.
Safety of off-label erythropoiesis stimulating agents in critically ill patients: a meta-analysis
Bita Mesgarpour,Benedikt H. Heidinger,Michael Schwameis,Calvin Kienbacher,Cathal Walsh,Susanne Schmitz,Harald Herkner +6 more
TL;DR: In critically ill patients, administration of ESAs is associated with a significant increase in clinically relevant thrombotic vascular events but not with other frequently reported adverse events and death, and results were robust against risk of bias and analysis methods.
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How to select a biosimilar
Niels Boone,Hugo van der Kuy,Michael G. Scott,Jill Mairs,Irene Krämer,Arnold G. Vulto,Rob Janknegt +6 more
TL;DR: An overview of an extensive set of 31 previously drawn biosimilar selection criteria is provided and how several of these criteria are covered by EMA regulations and guidelines are described.
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Greek students’ attitudes, perception and knowledge regarding generic medicines in times of economic crisis: a cross-sectional study
Philippe Domeyer,Vasiliki Katsari,Pavlos Sarafis,Vassilis Aletras,Dimitris Niakas,Dimitris Niakas +5 more
TL;DR: This study demonstrated a mixed attitude of students regarding generic medicines and underlines the importance of addressing and correcting health management students’ misbeliefs about generics’ quality and utility.
References
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The protein science of biosimilars.
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TL;DR: A sea change is occurring in the off-patent drug manufacturing industry with a first wave of biotechnologically derived products reaching the end of their patent lives, but recombinant proteins are in a different league from their chemical predecessors in terms of molecular complexity.