| Similar biological medicinal products currently licensed in the European union - Overview of non-clinical study programs. | |
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MedLine Citation:
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PMID: 21871818 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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In the EU, a regulatory framework has been established which defines general conditions for marketing authorisation approval of similar biological medicinal products (SBMPs). In addition, the framework provides product-class specific recommendations for non-clinical evaluation of specific SBMPs containing as active substance recombinant somatropin, granulocyte-colony stimulating factor (G-CSF), erythropoietin, interferon alpha, insulin or low molecular weight heparins. During the last years, a number of SBMPs have been succesfully licensed in the EU. This article summarizes the non-clinical evaluations performed for these medicinal products and provides a comparison with the current requests for non-clinical evaluation as laid down in the respective EU regulatory guidelines. |
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Authors:
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Hans-Karl Heim |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-8-24 |
Journal Detail:
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Title: Biologicals : journal of the International Association of Biological Standardization Volume: - ISSN: 1095-8320 ISO Abbreviation: - Publication Date: 2011 Aug |
Date Detail:
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Created Date: 2011-8-29 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9004494 Medline TA: Biologicals Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2011 The International Alliance for Biologicals. Published by Elsevier Ltd. All rights reserved. |
Affiliation:
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Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Germany. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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