| Registration of similar biological products - Singapore's approach. | |
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MedLine Citation:
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PMID: 21783381 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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The expiration of patents on many biological medicinal products has prompted the development of these products as similar biological (biosimilar) products. The standard approach of demonstration of bioequivalence for chemical generic products is scientifically not applicable for biosimilar products. The biosimilar product approach, based on comparability (demonstration of similarity), should be adopted. In view of the impending submissions and to facilitate access of such products at a more affordable price in Singapore, the Health Sciences Authority (HSA) formalised the procedures and requirements for registration of biosimilar products in 2009. HSA has published the "Guideline on Registration of Similar Biological Products in Singapore" which describes the basic principles, submission procedure, and requirements pertaining to documentation, pharmacovigilance, and post-approval batch release for the registration of biosimilar products. This article provides a brief overview as well as key points on the registration of medicinal products and biosimilar products in Singapore. |
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Authors:
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Jalene Poh; Kai Tong Tam |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-7-21 |
Journal Detail:
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Title: Biologicals : journal of the International Association of Biological Standardization Volume: - ISSN: 1095-8320 ISO Abbreviation: - Publication Date: 2011 Jul |
Date Detail:
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Created Date: 2011-7-25 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9004494 Medline TA: Biologicals Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2011 The International Alliance for Biologicals. Published by Elsevier Ltd. All rights reserved. |
Affiliation:
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Health Products Regulation Group, Health Sciences Authority, 11 Biopolis Way #11-01, Singapore 138667, Singapore. |
Export Citation:
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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