| The challenges of immunogenicity in developing biosimilar products. | |
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MedLine Citation:
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PMID: 19579165 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Unwanted immunogenicity is a significant issue affecting most biotherapeutic products, including subsequent entry biological (SEB) medicines. Such immunogenicity can be associated with adverse reactions and can cause impaired clinical responses to the biotherapeutic. This feature article provides an overview of the challenges facing the biotechnology industry with regard to the prediction and assessment of immunogenicity of SEBs and, in particular, biosimilar products. In addition, the available guidance on assessing the immunogenicity of biotherapeutic products is discussed. |
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Authors:
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Meenu Wadhwa; Robin Thorpe |
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Publication Detail:
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Type: Journal Article; Review |
Journal Detail:
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Title: IDrugs : the investigational drugs journal Volume: 12 ISSN: 2040-3410 ISO Abbreviation: IDrugs Publication Date: 2009 Jul |
Date Detail:
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Created Date: 2009-07-06 Completed Date: 2010-02-01 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100883655 Medline TA: IDrugs Country: England |
Other Details:
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Languages: eng Pagination: 440-4 Citation Subset: IM |
Affiliation:
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National Institute for Biological Standards and Control, Hertfordshire, UK. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Antibodies / analysis Antibody Formation / drug effects, immunology* Drug Approval Drug Discovery* / legislation & jurisprudence, methods Drug Evaluation, Preclinical Drug Industry* / legislation & jurisprudence, methods Government Regulation Guidelines as Topic Humans Immunoassay Pharmaceutical Preparations / adverse effects* Recombinant Proteins / adverse effects*, immunology |
| Chemical | |
Reg. No./Substance:
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0/Antibodies; 0/Pharmaceutical Preparations; 0/Recombinant Proteins |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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