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The Tortoise and the Hare: Evolving Regulatory Landscapes for Biosimilars

Paper ID Volume ID Publish Year Pages File Format Full-Text
36829 45270 2016 14 PDF Available
Title
The Tortoise and the Hare: Evolving Regulatory Landscapes for Biosimilars
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.

TrendsAfter a burst of activity from 2006 to 2008, EMA approvals of biosimilars has slowed.FDA released new guidances from 2013–2015 and approved its first biosimilar in 2015.Despite recent regulatory progress, the field is still problematic.‘Biobetters’ may yet emerge as a more attractive alternative for biologics developers.

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Publisher
Database: Elsevier - ScienceDirect
Journal: - Volume 34, Issue 1, January 2016, Pages 70–83
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us