Dr Reddy’s receives Health Canada approval for generic Semaglutide Injection

Dr. Reddy’s Laboratories announced that it has received a Notice of Compliance (NOC) from Health Canada for its generic Semaglutide Injection. The company becomes the first to receive market authorisation for generic Semaglutide Injection in Canada, ahead of Health Canada’s review target date. The authorisation covers the 2 mg/pen (1.34 mg/mL) and 4 mg/pen (1.34 mg/mL). The company stated that launch preparations are underway to make the treatment available to patients in Canada.

According to the Public Health Agency of Canada, around 3.9 million people, representing 9.7 per cent of the population aged over one year, live with diagnosed diabetes. In addition, over 6 per cent of adults in Canada live with prediabetes. The number of people living with diabetes is expected to increase as the population ages and grows. GLP-1 receptor agonist therapies, including semaglutide, are supported by clinical evidence demonstrating improvements in glycaemic control, measured by HbA1c, in adults with type 2 diabetes when used as part of a diabetes management strategy. Canada is recognised as the second-largest market for semaglutide.

Health Canada’s approval reflects Dr. Reddy’s capabilities in complex generics and peptide-based therapeutics, supported by in-house API and formulation development. The API is produced in-house, while finished product manufacturing is carried out by OneSource Specialty Pharma Limited.

Erez Israeli, Chief Executive Officer, Dr. Reddy’s, said: “The approval of our generic Semaglutide Injection by Health Canada represents a significant milestone in our GLP-1 journey and underscores our expertise in complex product development, peptide science, and our ability to meet stringent global regulatory standards. Canada remains a priority market for us. As the first company to receive market authorization for generic Semaglutide Injection in Canada, we remain dedicated to expanding access to innovative, high-quality, affordable GLP-1 treatments for patients with diabetes in the country. Additionally, with our in-house development capabilities, we are committed to ensuring a reliable and consistent supply of this important therapy for Canadian patients. This approval further fortifies our long-standing presence in Canada and enhances our diabetes management portfolio for regulated markets.”

Semaglutide Injection is indicated for once-weekly treatment of adult patients with type 2 diabetes to improve glycaemic control. It is used in combination with diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance; with metformin when diet and exercise plus maximum tolerated dose do not achieve adequate glycaemic control; with metformin and a sulfonylurea when dual therapy is insufficient; with metformin or a sulfonylurea and a sodium-glucose cotransporter 2 inhibitor when control is not achieved; and with basal insulin and metformin when required.

Semaglutide has not been studied in combination with prandial insulin and is not a substitute for insulin. It should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. The company advised consulting the product monograph for prescribing information, warnings, adverse reactions, and contraindications.