| Biosimilars: current status and future directions. | |
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MedLine Citation:
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PMID: 20384525 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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IMPORTANCE OF THE FIELD: Expiration of patents covering biopharmaceuticals, has provided opportunities for pharmaceutical companies to develop, produce and market biosimilars or follow-on biologicals. However, there have been concerns over the degree of similarity of these complex drugs in addition to the hope that their introduction may lower the cost of such expensive medicinal products. AREAS COVERED IN THIS REVIEW: The introduction/manufacturing considerations, immunogenicity and regulatory approaches to biosimilars around the world. In addition, arguments and techniques employed by pharmaceutical companies to advance or discredit biosimilar drugs will be outlined. Issues with post-marketing surveillance programmes and their limitations are described. WHAT THE READER WILL GAIN: This evaluation outlines the controversial issues associated with introduction of biosimilar medicines across a range of pharmacological indications. Also the differences between regulatory approved medicines and biopharmaceutical products not subjected to regulatory approval ('B-NSRA') are highlighted. The review is limited by the rapid changes in regulatory approval and licencing of biosimilars. TAKE HOME MESSAGE: Hopefully biosimilar medicines will allow more widespread availability of expensive biopharmaceutical products. Clinicians need to be wary of non-transparent promotion of innovator/biosimilar products. |
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Authors:
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Simon D Roger |
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Publication Detail:
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Type: Journal Article; Review |
Journal Detail:
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Title: Expert opinion on biological therapy Volume: 10 ISSN: 1744-7682 ISO Abbreviation: Expert Opin Biol Ther Publication Date: 2010 Jul |
Date Detail:
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Created Date: 2010-06-09 Completed Date: 2010-09-14 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101125414 Medline TA: Expert Opin Biol Ther Country: England |
Other Details:
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Languages: eng Pagination: 1011-8 Citation Subset: IM |
Affiliation:
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Renal Unit, Gosford Hospital, Holden Street, Gosford, 2250, NSW, Australia. sroger@nsccahs.health.nsw.gov.au |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Biological Products / adverse effects, biosynthesis, chemistry, economics, immunology, therapeutic use* Biotechnology / trends* Consumer Product Safety Drug Approval Drug Costs Health Services Accessibility Humans Patents as Topic Protein Conformation Recombinant Proteins / adverse effects, biosynthesis, chemistry, economics, immunology, therapeutic use* Risk Assessment Structure-Activity Relationship Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Biological Products; 0/Recombinant Proteins |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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