Biosimilars: An Update
Saravanan Bhojaraj1, Thirumoorthy Durai Ananda Kumar2, Abhinav Raj Ghosh1, BS Sushmitha1, Srinivasan Ramamurthy3, Thirunavukkarasu Velusamy4, Thiyagarajan Ramesh5, MK Jayanthi6, Musthafa Mohamed Essa7, Saravana Babu Chidambaram1, M. Walid Qoronfleh8
1 Department of Pharmacology, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru-570015, Karnataka, India
2 Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru-570015, Karnataka, India
3 College of Pharmacy & Health Sciences, University of Science and Technology of Fujairah, Fujairah, UAE
4 Department of Biotechnology, School of Biotechnology and Genetic Engineering, Bharathiar University, Coimbatore 641046, Tamil Nadu, India
5 Department of Basic Medical Sciences, College of Medicine, Prince Sattam Bin Abdulaziz University, Al-Kharj-11942, Kingdom of Saudi Arabia
6 Department of Pharmacology, JSS Medical College, JSS Academy of Higher Education & Research, Mysuru-570015, Karnataka, India
7 Department of Food Science and Nutrition, CAMS, Sultan Qaboos University, Muscat, Oman
8 Research and Policy Department, World Innovation Summit for Health (WISH), Foundation, P.O. Box 5825, Doha, Qatar
PhD, MBA M. Walid Qoronfleh
Research and Policy Department, World Innovation Summit for Health (WISH), Qatar Foundation, P.O. Box 5825, Doha
PhD, FASc(AW) Saravana Babu Chidambaram
Associate Professor, Department of Pharmacology, JSS College of Pharmacy, Mysuru, Karnataka 570015.
Source of Support: None, Conflict of Interest: None
Biologics are medicines primarily derived from living systems and produced through recombinant DNA (rDNA) and monoclonal technologies. Generic version of biologics with improved efficacy and safety is called biosimilar. Patent and copyright expiration of biological products permits the entry of biosimilars. Synthesis of biosimilars involves two main processes, such as monoclonal antibodies and rDNA technology, and characterized by various methods such as posttranslational modification, mass spectrometry, peptide mapping, three-dimensional (high-order) structure, X-ray crystallography, ion mobility spectrometry, and hydrogen deuterium exchange mass spectrometry. Though both generic and biosimilar products follow the same regulatory approval, the requirements are not the same due to the variability in composition and instability. Hence, it is essential to develop pharmacokinetic and pharmacodynamic data to support the efficacy and safety data on biosimilars. This review summarizes the recent updates on biosimilars, synthesis, characterization, and current market status. Brief information on the role of biosimilars in multiple sclerosis is also provided in the review.