| Clinical programs in the development of similar biotherapeutic products: Rationale and general principles. | |
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MedLine Citation:
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PMID: 21911300 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Similar biotherapeutic products (SBPs) or biosimilars are biologics developed by pharmaceutical manufacturers to match originator biologics that have been on the market for a long time and lost their exclusivity (patent and market protection). The recently issued WHO guidelines on evaluation of SBPs provide clear guidance for manufacturers and regulators on how to develop and gain approval for these products. The present contribution illustrates the rationale for and general principles of the clinical programs used in the development of SBPs, taking the example of the three biosimilar products developed and marketed in Europe by Sandoz, namely growth hormone (Omnitrope(®), the first ever EU biosimilar approval), erythropoietin α (Binocrit(®)), and filgrastim (Zarzio(®)). |
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Authors:
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Alexander Berghout |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-9-10 |
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 Sep |
Date Detail:
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Created Date: 2011-9-13 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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Sandoz Biopharmaceuticals, Industriestrasse 25, D-83607 Holzkirchen, Germany. |
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Descriptor/Qualifier:
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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