Diabetic drug surge: Dr Reddy’s gets Health Canada nod for generic semaglutide injection

Dr. Reddy’s Laboratories has received approval from Health Canada for its generic semaglutide injection, strengthening the Indian drugmaker’s presence in the fast-growing global market for GLP-1 diabetes therapies.

The company said on Tuesday that Health Canada granted a Notice of Compliance (NOC) for the product ahead of the regulator’s review target date. The approval covers the 2 mg/pen and 4 mg/pen presentations of the injection.

Semaglutide is the active ingredient in Ozempic, the blockbuster diabetes drug developed by Novo Nordisk. The therapy belongs to the GLP-1 receptor agonist class of drugs, which have witnessed strong global demand for diabetes and weight management treatments.

Dr Reddy’s said it is preparing to launch the product in Canada, which it described as the world’s second-largest market for semaglutide.

“Canada remains a priority market for us. We remain dedicated to expanding access to innovative, high-quality, affordable GLP-1 treatments for patients with diabetes in the country,” said Erez Israeli, chief executive officer of Dr Reddy’s.

The approval comes as pharmaceutical companies globally increase investments in GLP-1 therapies, one of the fastest-growing segments in the pharmaceutical industry amid rising diabetes and obesity prevalence.

According to data cited by the company from the Public Health Agency of Canada, around 3.9 million people in Canada, or 9.7% of the population above one year of age, live with diagnosed diabetes. More than 6% of adults in the country also live with prediabetes.

Dr Reddy’s said the active pharmaceutical ingredient (API) for the product is manufactured entirely in-house, highlighting the company’s capabilities in peptide-based therapies and complex generics.

Commercial manufacturing of the formulation will be supported by partner OneSource Specialty Pharma Limited, which is serving as the contract development and manufacturing organisation (CDMO) partner for the programme.

OneSource said it would provide scale-up and commercial manufacturing support from its US FDA-approved manufacturing facility in Bengaluru.

“The partnership is designed to ensure reliable and scalable commercial supply from OneSource’s US FDA-approved flagship manufacturing facility in Bengaluru,” the company said in a statement.

Neeraj Sharma, chief executive officer and managing director of OneSource Specialty Pharma, said the approval strengthens the collaboration between the two companies in peptide-based therapies.

Industry analysts say Indian pharmaceutical companies are increasingly expanding into peptide therapies, injectables and complex generics as they seek higher-value opportunities in regulated global markets.