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Erschienen in: Targeted Oncology 4/2012

01.12.2012 | Review

Biosimilars and market access: a question of comparability and costs?

verfasst von: Steven Simoens, Gilbert Verbeken, Isabelle Huys

Erschienen in: Targeted Oncology | Ausgabe 4/2012

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Abstract

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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Metadaten
Titel
Biosimilars and market access: a question of comparability and costs?
verfasst von
Steven Simoens
Gilbert Verbeken
Isabelle Huys
Publikationsdatum
01.12.2012
Verlag
Springer-Verlag
Erschienen in
Targeted Oncology / Ausgabe 4/2012
Print ISSN: 1776-2596
Elektronische ISSN: 1776-260X
DOI
https://doi.org/10.1007/s11523-011-0192-7

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