Dr Reddy’s Labs gets nod to study popular weight loss medication

While a bioequivalence study essentially establishes that two versions of the same drug get absorbed in a similar manner in the body, a phase-III clinical trial looks at the effective outcome of administering the drug. “Phase-III clinical trial waiver can be considered based on the review of bioequivalence study report by the SEC committee,” the minutes of the meeting of the Subject Expert Committee (SEC) on endocrinology and metabolism said.

Semaglutide is sold as Ozempic for the treatment of diabetes and Wegovy for obesity by Danish company Novo Nordisk. There is also an oral semaglutide medicine that is sold under the brand name Rybelsus, which is available in India as well.

The SEC had earlier this year recommended the import of another drug from the same category — Tirzepatide sold under the brand name Mounjaro by American firm Eli Lilly.