India-based company Anthem Biosciences (AnthemBio) announced that it has launched its human insulin ‘similar biologic’ InsuTrend in India.
Insulin human (rDNA) is a polypeptide hormone structurally identical to human insulin synthesized through rDNA technology. It regulates the metabolism of carbohydrates, fats and protein by promoting the absorption of glucose from the blood into liver, fat and skeletal muscle cells. It is given once or twice daily to help control the blood sugar level of those with diabetes.
InsuTrend is a similar biologic of Eli Lilly’s Humulin (insulin human rDNA) and Novo Nordisk’s human insulin, which is sold under several trade names, including Actrapid, Actraphane, Insulatard, Mixtard and Protaphane.
Similar biologics have been on the market in India for some years already and India has by far shown the greatest acceptance of such products. However, regulatory guidelines for similar biologics were only implemented in September 2012. Prior to this, similar biologics were approved in India following the generics pathway, but with more data being required [1].
The launch marks 100 years since the discovery of insulin. Drs Frederik Banting and Charles Best discovered the life-changing drug in the summer of 1921, exactly 100 years ago. Dr Banting sold the patent rights for insulin to the University of Toronto for US$1, famously claiming that ‘insulin does not belong to me, it belongs to the world’. Although insulin treatment is not a cure, this breakthrough has saved millions of lives and, providing treatment for a disease that was previously considered a death sentence.
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘similar biologics’ approved in India might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Aug 27]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
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Source: Anthem Biosciences
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