| Biosimilars approval process. | |
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MedLine Citation:
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PMID: 19925842 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier. |
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Authors:
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Leyre Zu?iga; Bego?a Calvo |
Publication Detail:
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Type: Journal Article Date: 2009-11-17 |
Journal Detail:
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Title: Regulatory toxicology and pharmacology : RTP Volume: 56 ISSN: 1096-0295 ISO Abbreviation: Regul. Toxicol. Pharmacol. Publication Date: 2010 Apr |
Date Detail:
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Created Date: 2010-03-03 Completed Date: 2010-06-03 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8214983 Medline TA: Regul Toxicol Pharmacol Country: United States |
Other Details:
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Languages: eng Pagination: 374-7 Citation Subset: IM |
Copyright Information:
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Copyright 2009 Elsevier Inc. All rights reserved. |
Affiliation:
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Pharmaceutical Technology Department, Faculty of Pharmacy, University of the Basque Country, Vitoria-Gasteiz, Spain. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Biological Products* Clinical Trials as Topic Consumer Product Safety / legislation & jurisprudence* European Union Government Regulation Legislation, Drug* Product Surveillance, Postmarketing |
| Chemical | |
Reg. No./Substance:
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0/Biological Products |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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