Apotex Health receives Health Canada OK for Sevmia

Executive Summary

• Apotex Health Corp. has become the first company to receive Health Canada approval for Sevmia (semaglutide injection), a generic equivalent of Wegovy, for chronic weight management in adults.
• The approval expands Apotex's portfolio in the diabetes and weight management sectors, following the recent approval of Apo-Semaglutide Injection.
• Sevmia was developed in partnership with Orbicular Pharmaceutical Technologies and is indicated for adults with obesity or overweight with comorbidities, as well as for reducing cardiovascular risk in specific patient groups.

Key Details

• Product: Sevmia (semaglutide injection), a generic equivalent of Wegovy.
• Regulatory Body: Health Canada.
• Status: First generic semaglutide for chronic weight management approved by Health Canada.
• Dosage Form: Multiuse prefilled pen delivering 1 mg doses (4 mg total per pen; concentration of 1.34 mg/mL).
• Indications:
  • Adjunct to reduced calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with at least one weight-related co-morbidity.
  • Reduction of risk of non-fatal myocardial infarction in adults with established cardiovascular disease and BMI ≥ 27 kg/m².
• Partnership: Developed in collaboration with Orbicular Pharmaceutical Technologies.
• Strategic Context: This approval complements the previously approved Apo-Semaglutide Injection, broadening Apotex's presence in Type 2 diabetes and chronic weight management markets.

Notable Quotes

• "For more than 50 years, Apotex has helped support access to affordable medicines for Canadians... This approval reflects our ongoing efforts to expand access to high-quality treatment options in areas of significant and growing needs for patients." — Martin Ares, President, Apotex Canada
• "We are pleased to collaborate with Apotex on this important program... The approval of Sevmia demonstrates the strength of our peptide development platform and the scientific rigour applied by both teams to meet Health Canada's requirements." — Dr. M.S. Mohan, Managing Director, Orbicular Pharmaceutical Technologies