| Pharmacy and pharmacology of biosimilars. | |
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MedLine Citation:
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PMID: 18560268 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Biosimilar medicines are biological medicinal products that can obtain a marketing authorization in the EU after the original product (biological reference medicine) has run out of patent. As a prerequisite, studies including clinical trials are to be conducted to compare the quality, safety, and efficacy of the biosimilar and reference medicine. Due to the specific characteristics of biopharmaceuticals like complex 3-dimensional (glyco) protein structure, immunogenicity, production in living organisms, which causes heterogeneity, complex manufacturing process and analysis, interchangeability of the biosimilar with its reference drug product is not guaranteed. In addition, INN (international non-proprietary name) naming and interchangeability, pharmacovigilance, and traceability are subjects for discussion. The aim of this article is to describe the pharmaceutical and pharmacological specialties of biosimilars and to inform about points to consider (like manufacturer, good handling practice, pharmacovigilance, costs), when the use of biosimilars comes into question. |
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Authors:
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I Krämer |
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Publication Detail:
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Type: Evaluation Studies; Journal Article; Review |
Journal Detail:
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Title: Journal of endocrinological investigation Volume: 31 ISSN: 1720-8386 ISO Abbreviation: J. Endocrinol. Invest. Publication Date: 2008 May |
Date Detail:
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Created Date: 2008-06-18 Completed Date: 2008-09-02 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7806594 Medline TA: J Endocrinol Invest Country: Italy |
Other Details:
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Languages: eng Pagination: 479-88 Citation Subset: IM |
Affiliation:
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Department of Pharmacy, Johannes Gutenberg University Hospital, 55101 Mainz, Germany. Kraemer@apotheke.klinik.uni-mainz.de |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Algorithms Drug Industry / methods*, trends Humans Immune System / drug effects Models, Molecular Pharmaceutical Preparations / analysis, chemical synthesis* Pharmacology / methods*, trends Pharmacy / methods*, trends Quality Control Therapeutic Equivalency* |
| Chemical | |
Reg. No./Substance:
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0/Pharmaceutical Preparations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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