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Weise M.,Federal Institute for Drugs and Medical Devices | Kurki P.,Finnish Medicines Agency | Wolff-Holz E.,Paul Ehrlich Institute | Bielsky M.-C.,Medicines and Healthcare Products Regulatory Agency | And 2 more authors.
Blood | Year: 2014

Despite the establishment of a specific approval pathway, the issuance of detailed scientific guidelines for the development of similar biological medicinal products (so-called "biosimilars") and the approval of several biosimilars in the European Union, acceptance of biosimilars in the medical community continues to be low. This is especially true in therapeutic indications for which no specific clinical trials with the biosimilar have been performed and that have been licensed based on extrapolation of efficacy and safety data from other indications. This article addresses the concerns frequently raised in the medical community about the use of biosimilars in such extrapolated indications and explains the underlying scientific and regulatory decision making including some real-life examples from recently licensed biosimilars. © 2014 by The American Society of Hematology. Source

Rath P.-M.,University of Duisburg - Essen | Saner F.,University of Duisburg - Essen | Paul A.,University of Duisburg - Essen | Lehmann N.,University of Duisburg - Essen | And 3 more authors.
Journal of Clinical Microbiology | Year: 2012

This prospective study evaluated the utility of the SeptiFast (SF) test in detecting 25 clinically important pathogens in 225 blood samples from 170 intensive care unit (ICU) patients with suspected sepsis after liver transplantation (LTX) or after other major abdominal surgery (non-LTX). SF yielded a significantly higher positivity rate in the LTX group (52.3%) than in the non-LTX group (30.5%; P = 0.0009). SF may be a powerful tool for the early diagnosis of bloodstream infections in LTX patients. Copyright © 2012, American Society for Microbiology. All Rights Reserved. Source

Eichler H.-G.,European Medicines Agency | Eichler H.-G.,Massachusetts Institute of Technology | Abadie E.,European Medicines Agency | Abadie E.,European Medicines Agency Committee for Medicinal Products for Human Use | And 11 more authors.
Nature Reviews Drug Discovery | Year: 2011

Drug regulatory agencies should ensure that the benefits of drugs outweigh their risks, but licensed medicines sometimes do not perform as expected in everyday clinical practice. Failure may relate to lower than anticipated efficacy or a higher than anticipated incidence or severity of adverse effects. Here we show that the problem of benefitgrisk is to a considerable degree a problem of variability in drug response. We describe biological and behavioural sources of variability and how these contribute to the long-known efficacy-effectiveness gap. In this context, efficacy describes how a drug performs under conditions of clinical trials, whereas effectiveness describes how it performs under conditions of everyday clinical practice. We argue that a broad range of pre- and post-licensing technologies will need to be harnessed to bridge the efficacy-effectiveness gap. Successful approaches will not be limited to the current notion of pharmacogenomics-based personalized medicines, but will also entail the wider use of electronic health-care tools to improve drug prescribing and patient adherence. © 2011 Macmillan Publishers Limited. All rights reserved. Source

Van Aerts L.A.,Medicines Evaluation Board CBG MEB | De Smet K.,Federal Agency for Medicines and Health Products FAMHP | Reichmann G.,Similar Biological Medicinal Products BMWP | Reichmann G.,Paul Ehrlich Institute | And 3 more authors.
mAbs | Year: 2014

The concept of biosimilars has spread from Europe to other regions throughout the world, and many regions have drafted regulatory guidelines for their development. Recently, a paradigm shift in regulatory thinking on the nonclinical development of biosimilars has emerged in Europe: In vivo testing should follow a step-wise approach rather than being performed by default. To not require animal testing at all in some instances can well be seen as a revolutionary, but science-based, step. Here, we describe the internal discussions that led to this paradigm shift. The mainstay for the establishment of biosimilarity is the pharmaceutical comparability based on extensive physicochemical and biological characterization. Pharmacodynamic comparability can be evaluated in in vitro assays, whereas pharmacokinetic comparability is best evaluated in clinical studies. It is considered highly unlikely that new safety issues would arise when comparability has been demonstrated based on physicochemical and in vitro comparative studies. © Leon AGJM van Aerts, Karen De Smet, Gabriele Reichmann, Jan Willem van der Laan, and Christian K Schneider. Source

Weise M.,Bundesinstitut For Arzneimittel Und Medizinprodukte | Bielsky M.-C.,Medicines and Healthcare Products Regulatory Agency | De Smet K.,Federal Agency for Medicines and Health Products | Ehmann F.,European Medicines Agency | And 16 more authors.
Blood | Year: 2012

Biosimilar medicinal products (biosimilars) have become a reality in the European Union and will soon be available in the United States. Despite an established legal pathway for biosimilars in the European Union since 2005 and increasing and detailed regulatory guidance on data requirements for their development and licensing, many clinicians, particularly oncologists, are reluctant to consider biosimilars as a treatment option for their patients. Major concerns voiced about biosimilars relate to their pharmaceutical quality, safety (especially immunogenicity), efficacy (particularly in extrapolated indications), and interchangeability with the originator product. In this article, the members and experts of the Working Party on Similar Biologic Medicinal Products of the European Medicines Agency (EMA) address these issues. A clear understanding of the scientific principles of the biosimilar concept and access to unbiased information on licensed biosimilars are important for physicians to make informed and appropriate treatment choices for their patients. This will become even more important with the advent of biosimilar monoclonal antibodies. The issues also highlight the need for improved communication between physicians, learned societies, and regulators. © 2012 by The American Society of Hematology. Source

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