Macleods Gets CDSCO Panel Nod to Conduct BE Studies for Semaglutide Prefilled Pens
New Delhi: Accepting the toxicity data submitted by Macleods Pharmaceuticals, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted permission to the firm to conduct bioequivalence (BE) studies for multiple strengths of its Semaglutide injection formulations.
The recommendations came during the SEC meeting held on December 17, 2025, where the firm presented detailed raw pathological and biochemical data from animal studies, along with a revised common BE study protocol (Protocol ID: BEQ-4074-SEMA-2025). The submissions were made in compliance with earlier SEC directions issued on April 22, 2025, and November 18, 2025.
The committee reviewed data for Semaglutide Injection pre-filled pens in multiple strengths, including 0.25 mg, 0.5 mg and 1 mg pre-filled pens (4 mg/3 ml), 2.0 mg pre-filled pens (8 mg/3 ml), as well as higher-dose presentations of 1.7 mg and 2.4 mg (9.6 mg/3 ml). The products are of synthetic origin.
Semaglutide is a glucagon-like peptide 1 receptor agonist used to improve glycemic control in type 2 diabetes mellitus, treat obesity, and reduce the risk of major adverse cardiovascular events in selected adults.
GLP-1 is a physiological hormone that promotes glycemic control via several different mechanisms, including insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion. The homeostasis of glucose is dependent on hormones such as insulin and amylin, which are secreted by the beta cells of the pancreas. Semaglutide is 94% similar to human GLP-1.
Analogs of this hormone, such as semaglutide, stimulate the synthesis of insulin by stimulating pancreatic islet cells and reducing glucagon secretion. They directly bind with selectivity to the GLP-1 receptor, causing various beneficial downstream effects that reduce blood glucose in a glucose-dependent fashion.
After detailed deliberations, the committee recommended accepting the presented toxicity data and recommended granting permission for the conduct of the BE study as per the protocol presented by the firm.
Further, the expert panel suggested that the BE report shall be submitted to CDSCO for further review by the committee and consideration of the CT study.
