| Biosimilars and market access: a question of comparability and costs? | |
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MedLine Citation:
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PMID: 22249657 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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This article discusses specific issues related to the market access of biosimilars. Biopharmaceuticals are complex molecules produced by living cells. Copies of these medicines, called biosimilars, are not identical to their reference medicine and therefore specific regulatory requirements apply. When considering the use of biosimilars, the question of the degree of comparability between a biosimilar and the reference biopharmaceutical needs to be considered for registration, pricing and reimbursement purposes in addition to the cost issue. To date, many key concepts (like clinically meaningful differences) remain undefined and the question of the degree of comparability is not yet resolved. |
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Authors:
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Steven Simoens; Gilbert Verbeken; Isabelle Huys |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-1-17 |
Journal Detail:
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Title: Targeted oncology Volume: - ISSN: 1776-260X ISO Abbreviation: - Publication Date: 2012 Jan |
Date Detail:
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Created Date: 2012-1-17 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101270595 Medline TA: Target Oncol Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Research Centre for Pharmaceutical Care and Pharmaco-economics, Faculty of Pharmaceutical Sciences, Katholieke Universiteit Leuven, Onderwijs en Navorsing 2, Herestraat 49, P.O. Box 521, 3000, Leuven, Belgium, steven.simoens@pharm.kuleuven.be. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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