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Gundert-Remy U.,Arzneimittelkommission der Deutschen Arzteschaft
Zeitschrift fur Allgemeinmedizin | Year: 2010

Biosimilars contain a biotechnologically produced protein, which is structurally similar to an original product with identical pharmacological effects already licensed in European Union. To meet ongoing discussions about drug safety of biosimilars regulatory documents about pharmaceutical quality and pharmacologic-toxicological and clinical investigations in comparison to the reference product were screened. Based on this documentation one can conclude that biosimilars are as effective as the originator product. Careful control is advised when switching a patient from the originator to a biosimilar product. With respect to safety the situation is similar to the administration of a newly approved drug with a drug molecule belonging to the same pharmacological class with a known spectrum of side effects. © Deutscher Ärzte-Verlag.


Research over the past two decades has untangled the molecular heterogeneity of cancer at the cellular level. The molecular techniques that have been developed in the past 5 to 10 years are dramatically improving our understanding of the genomic aberrations that underlie the malignant transformation of normal cells. At the same time, however, advances in our understanding of the genetic basis of solid tumours and hematologic malignancies have revealed how complex cancer is, and consequently how much more challenging it is in many of the more common cancers to identify the right drug for the right patient in the adequate dose at the right time. Given the slow pace of translation from genome science to individualised medicine in oncology, this expert review, mainly taking into account recently published perspective articles and reviews, describes the molecular heterogeneity of cancer, the difficulties in developing novel molecularly targeted agents, and the need for developing biomarkers to optimise drug development and clinical use. Distinct types of biomarkers, breakthoughs as well as disappointments in the clinical implementation of biomarkers and targeted therapeutics into clinical practice are discussed by focusing on four targeted anti-cancer drugs. Finally, as clinical biomarker tests that predict response to particular therapies will play an important role in achieving stratified medicine in the near future, this article will conclude by giving some recommendations for effective biomarker evaluation and clinical trial designs for predictive biomarker validation.


The market authorisation or extension of indication for all oncology drugs in Europe is now based on Regulation (EC) No. 726/2004, a centralised procedure of the European Medicines Agency (EMA). Studies in recent years have highlighted deficiencies in pivotal studies. For example, the requirements of the EMA are not always consistently followed and studies are stopped prematurely after only interim analysis that at this time point shows improved efficacy with regard to the comparator arm. Our current analysis of the European Assessment Reports (reporting period: 01/01/2009 to 08/13/2012) on 29 drugs for 39 oncology indications shows that the quality of the trials for market authorisation has improved in several respects. Primary endpoints recommended by the EMA and the Food and Drug Administration (FDA) such as overall survival and progression-free survival are used, and only one study was conducted as a phase II trial with no comparator arm. In contrast, oncology drugs that are approved for the treatment of rare diseases (orphan drugs) are based on small studies which are often carried out without blinding, are not randomised and investigate surrogate endpoints. To answer patient-relevant issues following market authorisation, it is necessary to conduct independent clinical studies. Increased public funding needs to be provided and bureaucratic hurdles have to be reduced. Only this will permit a more efficient use of limited health care resources and allow to improve the quality of care for cancer patients. Copyright © 2013 S. Karger AG, Basel.


Radbruch L.,Universitatsklinikum Bonn | Alt-Epping B.,Universitatsmedizin Gottingen | Rolke R.,Universitatsklinikum Bonn | Ujeyl M.,Arzneimittelkommission der Deutschen Arzteschaft | Nauck F.,Universitatsmedizin Gottingen
Schmerz | Year: 2012

The Drug Commission of the German Medical Association has decided to develop treatment guidelines for palliative care. A series of systematic reviews was commissioned to evaluate the evidence for interventions of common symptoms that burden patients and care givers. A common methodology for all reviews is described in this paper. The methodology was based on the work of the European Palliative Care Research Collaborative. Standardized search strategies were identified in PubMed and Embase and these templates were then adapted by the authors of the reviews according to their needs. The template included the target group (patients and disease entities), indications (symptoms) and interventions (medicines and classes of medicines). Target groups included search terms on palliative or hospice care, cancer, neurodegenerative diseases, HIV/AIDS as well as cardiac and pulmonary failure. The number of relevant hits was surveyed in the first 40 hits in some exemplary searches. This was used for fine tuning the search templates and to optimize the search strategy in order to achieve the highest possible yield with the minimum possible effort. The review series was performed using this search strategy. Every review graded the quality of the included evidence following categories of the Drug Commission of the German Medical Association. Based on these results and recommendations the treatment guidelines will be formulated which will offer concise and evidence-based guidelines for general palliative medicine, offering primary care givers guidance for adequate palliative care in severely ill and dying patients. The English full text version of this article will be available in SpringerLink as of November 2012 (under "Supplemental"). © Deutsche Schmerzgesellschaft e.V. Published by Springer-Verlag - all rights reserved 2012.


Janzen R.W.C.,Arzneimittelkommission der Deutschen Arzteschaft | Ludwig W.D.,Arzneimittelkommission der Deutschen Arzteschaft
Zeitschrift fur Rheumatologie | Year: 2012

The off-label use of approved pharmaceuticals outside the authorized status is implemented in pharmacotherapy of many diseases, especially for rare diseases and in cases of therapy resistance. The German regulations are presented and analyzed and the relative literature is discussed.

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