Leading pharmaceutical company Dr Reddy’s Labs has received permission from the Central Drug Authority (CDA) to carry out a bioequivalence study of semaglutide injection, which is an active ingredient in weight loss drugs.
The nod for the bioequivalence study comes after the drug maker approached the Drugs Controller General of India (DCGI) seeking a waiver of the phase-III clinical trial of the drug and its market authorisation, reported PTI. The Subject Expert Committee (SEC) of the CDA has given a go-ahead to Dr Reddy’s Labs to conduct a bioequivalence study. This study will ensure the bioequivalence or the safety and efficacy of the newly launched drug in India.
What is Semaglutide?
Semaglutide is a class of medications which is known as the glucagon-like peptide-1 receptor agonists, or GLP-1 RAs. It is similar to the GLP-1 hormone, which is released in the liver when we consume food. The primary role of GLP-1 is to initiate the body to produce more insulin, which can reduce blood sugar or glucose levels. Doctors have been prescribing Semaglutide for more than 15 years to treat Type 2 diabetes.
However, GLP-1 in a larger amount may also interact with the parts of the brain that decrease the appetite and signal to feel full. When the GLP-1 is consumed with proper diet and exercise, it can result in weight loss and reduce the risk of cancer, diabetes and heart disease in people who are suffering from obesity or are overweight.
Novo Nordisk’s oral semaglutide, namely ‘Rybelsus’, is being considered to be a game-changer in treating Type 2 diabetes. It was launched early last year in India. The oral semaglutide is marketed in three different variations in India 3 mg, 7mg and 14 mg. Meanwhile, it is being sold at a high price of about Rs 10,000 a month.
The other two injectable products, ‘Ozempic’ and ‘Wegovy’, have not been launched in India yet, but their international popularity has been putting major pressure on the supply of the active ingredient, Semaglutide. Ozempic is expected to make $12.5 billion in sales in 2023, a growth of 23% while Wegovy, the drug approved for weight loss netted $1 billion in sales in just one quarter seeing its sales rise 363% in just the 1H of 2023.
Recently, the Tesla founder, Elon Musk had also opened up about using the drug when he mentioned Wegovy as his secret of looking fit, ripped and healthy.
Hey, @elonmusk what’s your secret? You look awesome, fit, ripped & healthy. Lifting weights? Eating healthy? pic.twitter.com/mYeOUOLvgH
— Eva McMillan ♥️ (@EvasTeslaSPlaid) October 1, 2022
Novo Nordisk is a pharmaceutical company engaged in innovating and developing treatments for serious and chronic diseases. The company became popular for being the most valuable company in Europe and has raised its guidance for the third time this year now expecting sales to rise as much as 40% due to money generated from these highly demanded drugs.
(Edited by : Sudarsanan Mani)
First Published: Oct 19, 2023 5:21 PM IST
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