World Journal of Pharmaceutical Research Sen Et Al
World Journal of Pharmaceutical Research Sen et al. World Journal of Pharmaceutical SJIF ImRepactsearch Factor 6.805 Volume 5, Issue 9, 1841-1866. Review Article ISSN 2277– 7105 BIOSIMILARS AS BIOACTIVE MOLECULAR CLONE 1Prof. Dr. Dhrubo Jyoti Sen*, 2Jahangir Nabi, 2Pooja Raj and 2Jainik Khamar 1Department of Pharmaceutical Chemistry, Shri Sarvajanik Pharmacy College, Gujarat Technological University, Arvind Baug, Mehsana-384001, Gujarat, India. 2Delhi Institute of Pharmaceutical Sciences & Research (DIPSAR), Mehrauli-Badarpur Road, Puspvihar, Sector-3, New Delhi-110017, India. ABSTRACT Article Received on 24 July 2016, Biologics are 200 to 1,000 times the size of a small molecule (generic) Revised on 12 August 2016, drug and far more structurally complex. Additionally, biologics and Accepted on 01 Sept 2016 biosimilars are manufactured in living cells, then extracted and DOI: 10.20959/wjpr201610-7121 purified, whereas small molecule drugs and generics are manufactured purely via chemical synthesis. These fundamental differences in *Corresponding Author complexity and large-scale manufacturing are at the core of why Prof. Dr. Dhrubo Jyoti Sen Department of biosimilars are not equal to generics. Biologics and biosimilars are Pharmaceutical Chemistry, produced in living cells with a multi-step process. Initially, a basic Shri Sarvajanik Pharmacy protein structure is ―translated‖ from a DNA sequence and then College, Gujarat modifications, including changes and additions, are made to that basic Technological University, protein structure. These later changes and additions are called post- Arvind Baug, Mehsana- 384001, Gujarat, India. translational modifications. The impact of post-translational modifications on a product is similar to the impact of a farming environment on growing tomatoes.
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