Year : 2019 | Volume
: 23 | Issue : 4 | Page : 400--406
Biosimilar insulins – What a clinician needs to know?
Sujoy Ghosh1, Saptarshi Bose2, Sandeep Gowda3, Pradip Mukhopadhyay1
1 Department of Endocrinology, IPGMER and SSKM Hospital, Kolkata, West Bengal, India
2 Scientific Advisor, Metabolics Medical Affairs, Bengaluru, Karnataka, India
3 Deputy Manager Medical Services, Metabolics Medical Affairs Biocon Ltd, Biocon LTD, Bengaluru, Karnataka, India
As the first biologics produced by recombinant deoxyribonucleic acid (DNA) technology were approved in the late 1980s and consequently the exclusive marketing rights of most of these biological medicinal products have expired or will expire very shortly, it is quite evident that biosimilars are being developed and marketed in developed as well as developing countries in line with these expiries. Hence, there is an explosion of published papers and scientific programs on biological medicinal products and biosimilar insulins in the last decade or so. Each of these papers or scientific programs generated more questions than providing clinically useful answers. The specific aim of the medical literature or scientific programs were blurred due to lot of attention (created by the innovators) directed towards confusing terminologies, past mishaps with biosimilars (in the era with the absence of regulatory guidelines for biosimilars) diverting our attention from the matters relevant to clinicians and patients. One of the principle reason behind this phenomenon has been our poor understanding of the manufacturing process, regulatory pathways, and study endpoints involved in developing a biosimilar in the present era. This drawback resulted in a nonsystematic approach in analyzing the biosimilars and apparently resulting in confusion. This review attempts at demystifying certain facets of frequently encountered information on biosimilars and acquire a personal understanding on the same, rather than depending on conflicting versions floated at different continuing medical educations (CMEs) and Diabetes Congresses.
Department of Endocrinology, IPGMER and SSKM Hospital, Kolkata, West Bengal
|How to cite this article:|
Ghosh S, Bose S, Gowda S, Mukhopadhyay P. Biosimilar insulins – What a clinician needs to know?.Indian J Endocr Metab 2019;23:400-406
|How to cite this URL:|
Ghosh S, Bose S, Gowda S, Mukhopadhyay P. Biosimilar insulins – What a clinician needs to know?. Indian J Endocr Metab [serial online] 2019 [cited 2019 Oct 16 ];23:400-406
Available from: http://www.ijem.in/article.asp?issn=2230-8210;year=2019;volume=23;issue=4;spage=400;epage=406;aulast=Ghosh;type=0