The Tortoise and the hare: evolving regulatory landscapes for biosimilars

Konara, Chamindika S., Barnard, Ross T., Hine, Damian, Siegel, Evan and Ferro, Vito (2015) The Tortoise and the hare: evolving regulatory landscapes for biosimilars. Trends in Biotechnology, 34 1: 70-83. doi:10.1016/j.tibtech.2015.10.009

Author Konara, Chamindika S.
Barnard, Ross T.
Hine, Damian
Siegel, Evan
Ferro, Vito
Title The Tortoise and the hare: evolving regulatory landscapes for biosimilars
Journal name Trends in Biotechnology   Check publisher's open access policy
ISSN 0167-7799
Publication date 2015-11-24
Year available 2015
Sub-type Article (original research)
DOI 10.1016/j.tibtech.2015.10.009
Volume 34
Issue 1
Start page 70
End page 83
Total pages 14
Place of publication Kidlington, Oxford, United Kingdom
Publisher Elsevier
Collection year 2016
Language eng
Abstract Challenges in demonstrating interchangeability and safety, as well as the ongoing evolution of regulations governing biosimilars, have meant that the development of the biosimilars industry has not been, and will not be, a carbon copy of the generics industry. Complexity in the development process reduces the cost advantages for biosimilars that generics offer over originators. There has been a marked difference in the number of biosimilars approved by the European Medicines Agency (EMA) and US FDA due to a lack of consensus and the different rates of progress in establishing both law and stable evidence-based regulatory guidelines for biosimilars. In this review, we provide a précis of the history and status of the regulatory regimes in the USA and Europe. Included is an assessment of market and nonmarket factors that may continue to influence the development of the biosimilars industry.
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2016 Collection
UQ Business School Publications
School of Chemistry and Molecular Biosciences
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Created: Fri, 04 Dec 2015, 10:45:56 EST by Mrs Louise Nimwegen on behalf of School of Chemistry & Molecular Biosciences