New approvals deliver innovative options for cancer, autoimmune disease, COPD, and RSV prevention
Canada’s regulatory landscape for innovative therapies is shifting, as Health Canada recently approved several landmark treatments that promise to impact patient outcomes and healthcare costs across chronic, rare, and high-burden conditions.
According to Apotex Inc., Health Canada has granted a Notice of Compliance for LOQTORZI (toripalimab), making it the first and only approved immuno-therapy for recurrent unresectable or metastatic nasopharyngeal carcinoma (R/M NPC).
This ultra-rare cancer, known for its aggressive nature, now has a new treatment option for adults, either in combination with cisplatin and gemcitabine or as a monotherapy for those who have progressed following platinum-based chemotherapy.
Allan Oberman, president and CEO of Apotex, described LOQTORZI as a “transformative therapy where none previously existed, addressing a critical unmet need.”
Nathaniel Bouganim of McGill University Health Centre emphasized that its availability “promotes equitable care for those facing this rare disease.”
In the autoimmune space, Biocon Biologics Ltd. reported Health Canada’s approval of YESINTEK (ustekinumab) and YESINTEK I.V., biosimilars to Stelara®, for moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
The approval, based on a comprehensive data package, confirms YESINTEK’s high similarity to Stelara in efficacy, safety, and immunogenicity.
Shreehas Tambe, CEO and managing director, stated that this milestone “enhances our immunology portfolio with a more affordable treatment option for Canadian patients living with chronic autoimmune conditions.”
Ramy Ayad, head of Canada, noted the company’s commitment to “advancing biosimilar adoption in Canada to improve outcomes for patients and deliver meaningful savings to the healthcare ecosystem.”
For respiratory health, Health Canada has approved Dupixent (dupilumab injection) as an add-on maintenance treatment for adults with COPD characterized by raised blood eosinophils inadequately controlled by standard inhaled therapies.
The BOREAS and NOTUS studies demonstrated a 30 percent and 34 percent reduction in moderate or severe exacerbations over one year, as reported by the manufacturer.
Ken Chapman of the University Health Network called this “an exciting discovery for some of my most at-risk patients,” while Jean Bourbeau of McGill University Health Centre highlighted the “huge unmet need in COPD with acute exacerbations,” noting the potential for targeted biologic therapy to change the standard of care.
Pfizer Canada ULC announced Health Canada’s expanded indication for ABRYSVO, the RSV vaccine, now approved for adults aged 18-59 at increased risk for lower respiratory tract disease, in addition to existing indications for older adults and infants via maternal immunization.
Shawn Edwards, Stratford General Hospital, underscored the significance, stating that RSV “can have serious consequences for adults with underlying health conditions,” and the new indication “can help protect more at-risk Canadians.”
These approvals reflect Health Canada’s ongoing efforts to broaden access to advanced therapies, supporting both patient well-being and the sustainability of the healthcare system.
