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

Biosimilars and market access: a question of comparability and costs? 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. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Targeted Oncology Springer Journals

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

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References (19)

Publisher
Springer Journals
Copyright
Copyright © 2012 by Springer-Verlag
Subject
Medicine & Public Health; Oncology; Biomedicine general
ISSN
1776-2596
eISSN
1776-260X
DOI
10.1007/s11523-011-0192-7
pmid
22249657
Publisher site
See Article on Publisher Site

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.

Journal

Targeted Oncology – Springer Journals

Published: Jan 17, 2012

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