Open access peer-reviewed scientific and medical journals.
Dove Medical Press is now a member of the Open Access Initiative
An Author's Guide
A guide to help authors get their paper published.
Support Open Access and Dove Press
Promotional Article Monitoring - further details
Favored Author Program
Real benefits for authors, including fast-track processing of papers.
Biosimilars: an overview
(15606) Total Article Views
Authors: Bhupinder Singh Sekhon, Vikrant Saluja
Published Date March 2011
Volume 2011:1 Pages 1 - 11
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
Cannotea Citeulike Del.icio.us Facebook LinkedIn Twitter
Other articles by Dr Bhupinder Sekhon
Readers of this article also read:
Call For Submissions
Submit Original Research Article, Review, Case Report, or Rapid Communication in Biosimilars
- Evolution of a domain conserved in microtubule-associated proteins of eukaryotes
- Overview of the LDL receptor: relevance to cholesterol metabolism and future approaches for the treatment of coronary heart disease
- Is gene activity in plant cells affected by UMTS-irradiation? A whole genome approach
- Discrimination between biological interfaces and crystal-packing contacts