Volume 11, Issue 3, June 2015, Pages 728–733
Rakshambikai Ramaswamy1 and Phani Kishore Thimmaraju2
1 19, KMJ Ascend 1st Cross, 17th C Main 5th Block, Koramangala, Bangalore - 560 095, India
2 19, KMJ Ascend 1st Cross, 17th C Main 5th Block, Koramangala, Bangalore - 560 095, India
Original language: English
Copyright © 2015 ISSR Journals. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Therapeutics by means of complex biological molecules is currently dominating the total drug space. Several such complex biologics nearing patent expiry, various attempts to launch their generic equivalents is on-going. With stringent regulatory guidelines in place, there is a necessity to understand the basic challenges and differences in the area of establishing comparability. A perspective on existing methods is provided which highlights key gaps in the existing technologies. The coming years would see more developments in the tools and platforms that enable comparability studies and statistical methods that can help extrapolate a quantitative measure for biosimilarity.
Author Keywords: Biosimilars, Micro-heterogeneity, Post-translational modifications, interchangeability.
Rakshambikai Ramaswamy1 and Phani Kishore Thimmaraju2
1 19, KMJ Ascend 1st Cross, 17th C Main 5th Block, Koramangala, Bangalore - 560 095, India
2 19, KMJ Ascend 1st Cross, 17th C Main 5th Block, Koramangala, Bangalore - 560 095, India
Original language: English
Copyright © 2015 ISSR Journals. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Therapeutics by means of complex biological molecules is currently dominating the total drug space. Several such complex biologics nearing patent expiry, various attempts to launch their generic equivalents is on-going. With stringent regulatory guidelines in place, there is a necessity to understand the basic challenges and differences in the area of establishing comparability. A perspective on existing methods is provided which highlights key gaps in the existing technologies. The coming years would see more developments in the tools and platforms that enable comparability studies and statistical methods that can help extrapolate a quantitative measure for biosimilarity.
Author Keywords: Biosimilars, Micro-heterogeneity, Post-translational modifications, interchangeability.
How to Cite this Article
Rakshambikai Ramaswamy and Phani Kishore Thimmaraju, “Technical hindrances in establishing biosimilarity - the final lap in the race,” International Journal of Innovation and Applied Studies, vol. 11, no. 3, pp. 728–733, June 2015.
