PharmaTher Launches Strategic Initiative to Pursue Health Canada Approval for Generic Semaglutide in Canada, Building on FDA-Approved Ketamine Success

Executive Summary

• PharmaTher Holdings announced a new strategic initiative to seek Health Canada approval for a generic version of semaglutide in Canada, with commercialization planned pending regulatory clearance.
• The company highlights the recent expiry of exclusivity for semaglutide in Canada (January 2026) and positions itself to become an early supplier, leveraging its FDA‑approved ketamine platform and manufacturing capabilities.
• Potential market opportunity is substantial: Ozempic® generated ~C$2.9 billion in Canadian sales in 2025, with the broader GLP‑1 receptor agonist market projected to reach ≈US$6.5 billion by 2033.

Key Details

• Regulatory Milestone: Pursuing Health Canada approval for generic semaglutide in 2026.
• Dose Coverage: Planned formulation range from 0.25 mg to 2.4 mg to cover the full treatment journey.
• Manufacturing Strategy: Partnering with a cost‑effective, high‑quality commercial sterile injectable manufacturer whose facilities are audited by health authorities.
• Platform Building: Scaling injectable capabilities to ensure long‑term supply reliability and enable future global partnerships.
• Market Context: Canadian exclusivity for semaglutide expired in Jan 2026, opening the market to generic competition.
• Economic Impact: Ozempic® sales ≈ C$2.9 billion (2025); GLP‑1 receptor agonist market potential ≈ US$6.5 billion by 2033 (Grand View Research).
• Previous Successes: FDA approval of ketamine and monetization of U.S. rights with expected proceeds >US$25 million, demonstrating regulatory and partnership execution capability.

Notable Quotes

“Canada's semaglutide market is entering a pivotal transition: demand is growing, and affordable access and reliable supply will matter,” said Fabio Chianelli, Founder, Chairman and CEO of PharmaTher. “We've already proven we can execute on FDA approval of injectable drugs… We are now applying that same execution playbook to pursue Health Canada approval for generic semaglutide and build a scalable sterile injectable platform for the obesity and diabetes market.”