Regulatory Approval
Apotex Health Corp (TSX:APTX) announced that Health Canada has granted approval for SEVMIA™, a generic version of the weight‑management drug Wegovy® (semaglutide injection). This marks the first time a generic equivalent of Wegovy® has been authorized for use in Canada.
Product Details and Partnership
SEVMIA™ is supplied in a multi‑use pre‑filled pen that delivers a 1 mg dose per injection, with each pen containing a total of 4 mg (concentration 1.34 mg/mL). The product was developed in partnership with Orbicular Pharmaceutical Technologies.
Indications
The approved indication specifies SEVMIA™ as an adjunct to a reduced‑calorie diet and increased physical activity for chronic weight management in adults who are obese (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight‑related comorbidity. Additionally, the drug is approved to reduce the risk of non‑fatal myocardial infarction in adults with established cardiovascular disease and a BMI ≥27 kg/m².
Portfolio Expansion
The approval follows Health Canada’s recent clearance of Apo‑Semaglutide Injection™ and broadens Apotex’s product portfolio across type 2 diabetes and chronic weight‑management therapies.
Company Overview
Apotex is a Canadian‑based global health company headquartered in Toronto, with regional offices in the United States, Mexico, and India. Its product range includes generic, biosimilar, and innovative branded pharmaceuticals, as well as consumer health products.