Back to Browse Journals » Biosimilars » Volume 1

Biosimilars: an overview

Authors Bhupinder Singh Sekhon, Vikrant Saluja

Published Date March 2011 Volume 2011:1 Pages 1—11

DOI http://dx.doi.org/10.2147/BS.S16120

Published 15 March 2011

Bhupinder Singh Sekhon, Vikrant Saluja
Institute of Pharmacy, PCTE Group of Institutes, Near Baddowal Cantt. (Ludhiana), India

Abstract: “Biologics”, considered one of the fastest growing sectors of the pharmaceutical industry, has introduced many new treatments to life-threatening and rare illnesses. The first generation of biopharmaceutical products manufactured using recombinant technologies was launched in the 1980s, and they are now on the way to patent expiration. As a result, research-based and generic pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes for original biologics, herein referred to as biosimilars. However, the process of introducing a biosimilar to an innovator product is far more complex than the relatively straightforward process of introducing a generic equivalent to an innovator product based on a new chemical entity. Biologics are produced by cells in culture or whole organisms, which are inherently more variable than chemical synthesis methods. Therefore, unlike generic pharmaceuticals, it is impossible to generate the same or identical copy of an innovator product. In this way, biosimilars are “similar but not the same” or in other words biosimilars are “the twin but not the clone” to the original biologic innovator product. Therefore the field of biosimilars presents several important challenges, including i) verification of the similarity, ii) the interchangeability of biosimilars and innovator products, iii) the possible need for unique naming to differentiate the various biopharmaceutical products, iv) regulatory framework, v) commercial opportunities as well as guidelines to assist manufacturers in product development, vi) intellectual property rights, and vii) public safety.
Keywords: biosimilars, biologics, innovator product, pharmacovigilance, regulatory

Download Article [PDF] 

Creative Commons License This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution - Non Commercial (unported, v3.0) License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php

Other articles by this author:

Nanotechnology in agri-food production: an overview

Sekhon BS

Nanotechnology, Science and Applications 2014, 7:31-53

Published Date: 20 May 2014

Matrix metalloproteinases – an overview

Bhupinder Singh Sekhon

Research and Reports in Biology 2010, 1:1-20

Published Date: 15 September 2010

Food nanotechnology – an overview

Bhupinder S Sekhon

Nanotechnology, Science and Applications 2010, 3:1-15

Published Date: 4 May 2010

Readers of this article also read: