High-Barrier / Complex Generics are versions of “specialty” brand-name medicines used to treat chronic and complex conditions such as asthma, hypertension, and osteoporosis, among others.

Like all generic medicines authorized for sale in Canada, High-Barrier / Complex Generics must meet Health Canada’s rigorous standards for quality, safety and effectiveness. What makes these medicines different is their complexity. They may have multiple active ingredients, complex formulations or specialized methods of delivery. Some also include Patient Support Programs to help patients access and use their medicines.

CGPA member companies are investing in the research, development, regulatory work, manufacturing capabilities, programs and services needed to bring these medicines to Canadian patients.  These investments will deliver substantial returns for Canada’s healthcare system. By introducing competition for higher-cost specialty brand-name medicines, High-Barrier / Complex Generics have the potential to generate hundreds of millions of dollars in savings for Canadians. 

Over the next five years, the generic pharmaceutical industry forecasts that more than half of new product launches could be High-Barrier / Complex Generics.  But realizing their full potential will require addressing barriers to market entry and increasing their adoption once they become available.  If adoption remains low, manufacturers have less incentive to make the significant investments required to bring these products to the Canadian market, and opportunities for substantial savings may be lost.

Switching to the generic versions of these medicines will allow employers, patients, and the healthcare system to reduce  prescription drug costs while maintaining the same high standards of quality, safety and effectiveness.