Health Canada approves Dr. Reddy's semaglutide for adults with type 2 diabetes

Dr. Reddy’s Laboratories said on May 15 that it launched a generic semaglutide injection in Canada for adults with type 2 diabetes, days after receiving Health Canada clearance. The company said the product is indicated for once-weekly treatment to improve glycemic control in combination with diet and exercise. Health Canada records show the approval was granted on April 28 through an abbreviated new drug submission that cited Novo Nordisk Canada’s Ozempic as the reference product. Health Canada said in a separate release that Canada was the first G7 country to authorize a generic semaglutide injection. ### When did Health Canada actually approve the drug? Health Canada’s notice of compliance database lists April 28, 2026, as the approval date for Dr. Reddy’s semaglutide injection. The filing was made by DR REDDYS LABORATORIES LTD as a prescription pharmaceutical under an abbreviated new drug submission, according to the agency’s database. The May 15 date cited in company posts and the launch announcement refers to commercial rollout, not the original regulatory authorization. (businesswire.com) Dr. Reddy’s said the launch followed receipt of the notice of compliance from Health Canada on April 28. ### What exactly was cleared for patients in Canada? Dr. Reddy’s said its semaglutide injection in Canada is indicated for the once-weekly treatment of adults with type 2 diabetes mellitus to improve glycemic control with diet and exercise. (health-products.canada.ca) The company said the drug is supplied as a sterile solution for subcutaneous injection in pre-filled pens in 2 mg/pen and 4 mg/pen strengths, each at a concentration of 1.34 mg/ml. (businesswire.com) Health Canada said the submission filed by Dr. Reddy’s was a generic version of Ozempic. The agency said the authorized product is indicated, like existing products, for adult patients with type 2 diabetes to manage blood sugar levels. ### Why is Canada drawing attention in semaglutide generics? Health Canada said on April 28 that the authorization marked the first generic semaglutide approved by the department and the first approved in the G7. (businesswire.com) The agency said it reviewed evidence from the company and found the drug met its criteria for safety, efficacy and quality for generic drugs. (canada.ca) Health Canada also described generic semaglutide products as complex synthetic products that are pharmaceutically equivalent to the brand-name biologic drug. The department said its review is intended to ensure any differences do not affect safety, efficacy or quality. ### Did Dr. Reddy’s disclose price or reimbursement details? (canada.ca) Dr. Reddy’s launch announcement did not include a Canadian list price, public reimbursement status or private coverage details. The company’s statement focused on the indication, pen formats and its broader GLP-1 plans. Erez Israeli, Dr. Reddy’s chief executive officer, said in the launch statement that the company was “pleased to launch” the product in Canada within days of approval and said the company remained committed to bringing “affordable GLP-1 therapies” to patients. (canada.ca) He did not provide pricing or formulary specifics in the statement. (businesswire.com) ### How crowded could this market become? Health Canada said on April 28 that it was reviewing eight other submissions for generic semaglutide from different companies. The department said it expected to make more regulatory decisions in the following weeks and months. The same Health Canada release said many generic medicines in Canada are 45% to 90% cheaper than brand-name versions, though it did not give a projected discount for semaglutide specifically. (businesswire.com) Any future price changes for patients will depend on manufacturer pricing, pharmacy stocking and reimbursement decisions by public and private plans. The last point is an inference based on how medicines reach patients in Canada; Dr. Reddy’s has not yet published those details. (canada.ca) ### What comes next for doctors, pharmacies and patients? Dr. Reddy’s said the product is now launched in Canada, which means the next concrete steps are pharmacy availability, wholesaler distribution and reimbursement decisions by payers. The company said the Canada rollout also builds on its recent India launch under the brand name Obeda. (canada.ca) Health Canada said it will continue to monitor the safety and effectiveness of generic semaglutide products authorized in Canada. The agency also said more decisions on other semaglutide filings are expected in the coming weeks and months. (canada.ca) (businesswire.com)