| Biosimilar epoetins and other "follow-on" biologics: update on the European experiences. | |
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MedLine Citation:
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PMID: 20706990 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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After the patents of biopharmaceuticals have expired, based on specific regulatory approval pathways copied products ("biosimilars" or "follow-on biologics") have been launched in the EU. This article summarizes experiences with hematopoietic medicines, namely the epoetins (two biosimilars traded under five different brand names) and the filgrastims (two biosimilars, six brand names). Physicians and pharmacists should be familiar with the legal and pharmacological specialities of biosimilars: The production process can differ from that of the original, clinical indications can be extrapolated, glycoproteins contain varying isoforms, the formulation may differ from the original, and biopharmaceuticals are potentially immunogenic. Only on proof of quality, efficacy and safety, biosimilars are a viable option because of their lower costs. |
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Authors:
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Wolfgang Jelkmann |
Publication Detail:
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Type: Journal Article; Review |
Journal Detail:
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Title: American journal of hematology Volume: 85 ISSN: 1096-8652 ISO Abbreviation: Am. J. Hematol. Publication Date: 2010 Oct |
Date Detail:
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Created Date: 2010-09-27 Completed Date: 2010-10-12 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7610369 Medline TA: Am J Hematol Country: United States |
Other Details:
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Languages: eng Pagination: 771-80 Citation Subset: IM |
Copyright Information:
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© 2010 Wiley-Liss, Inc. |
Affiliation:
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Institute of Physiology, University of Luebeck, Ratzeburger Allee 160, Luebeck, Germany. jelkmann@physio.uni-luebeck.de |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Anemia
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etiology,
therapy Antineoplastic Agents / adverse effects Biological Products / economics, pharmacokinetics, standards, therapeutic use* Chronic Disease Drug Utilization Erythropoietin, Recombinant / economics, immunology, pharmacokinetics, therapeutic use* European Union Filgrastim / therapeutic use Guidelines as Topic Humans Isoantibodies / biosynthesis Kidney Diseases / blood, complications Legislation, Drug Marketing Neoplasms / blood, complications, drug therapy Patents as Topic Quality Control Recombinant Proteins / economics, immunology, pharmacokinetics, therapeutic use Red-Cell Aplasia, Pure / etiology Therapeutic Equivalency World Health Organization |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents; 0/Biological Products; 0/Erythropoietin, Recombinant; 0/Isoantibodies; 0/Recombinant Proteins; 0/pegfilgrastim; 121181-53-1/Filgrastim |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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