Dr Reddy’s Laboratories has got a go-head from the Subject Expert Committee (SEC) under India’s drug regulatory authority to conduct a bioequivalence study required to establish the safety and efficacy of the blockbuster weight loss drug Semaglutide on the Indian population.
Dr Reddy’s had approached the SEC in April with a proposal for manufacture and marketing of synthetically developed Semaglutide injection 2mg/1.5ml (1.34mg/ml) and Semaglutide injection 4mg/3ml (1.34mg/ml). The company had also sought a waiver of BE study and Phase III clinical trial.
However, the SEC recommended the company conduct a bioequivalence study and asked it to submit the protocol for the same for further review.
At a SEC meet on September 29, “the committee recommended for grant of permission to conduct bioequivalence study as per protocol presented by the firm,” as per the minutes of the meeting.
The committee said the Phase-III clinical trial waiver can be considered based on the review of the bioequivalence study report by the committee, it further said.
Approved by the US Food and Drug Administration, Semaglutide medications mimic the body’s GLP-1 hormone to help with insulin production and signal the brain to reduce appetite.
While Ozempic was approved in 2017 for treatment of type 2 diabetes, Wegovy was approved in 2021 to treat obesity.
Touted to be a game changer for treatment of Type 2 Diabetes, Novo Nordisk’s launched oral semaglutide (Rybelsus) last year in India. The pill is marketed in three strengths (3, 7 and 14 mg), and is priced at about ‘10,000 a month.
However, doctors say that drugs available in India for weight loss are not comparable to the newer agents like Wegovy and Ozempic.
“We do have drugs from the same class. And, in fact, even the same drug, but not in the format or the composition that could result in the kind of weight loss for which the newer drugs are getting famous. So that 10-15 kg weight loss is not easily achieved by the medications that we have right now,” said Dr Ambrish Mithal, chairman endocrinology and diabetes, Max healthcare.
Dr Anoop Misra, chairman, Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology, said weight loss is much better with injectables.
Dr Misra has also cautioned against the indiscriminate use of the drug. Reports suggest that obese patients in the US are seeking these weight loss drugs without being under close medical supervision.
“There is an unusual hype regarding the latest weight loss injections and medicines. They are costly and have serious side effects. Those with family history of thyroid, cancer or with thyroid lump should see their physician for proper advice,” he said.
Both drugs are under patent so a launch may be disputed before the term of the valid patent period. Novo Nordisk did not respond to an email sent by ET.
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