Over the past 20 years innovative biotech therapies, or "biologics", have delivered breakthrough medical treatments for serious and life-threatening illnesses, such as cancer, multiple sclerosis, diabetes, and HIV/AIDS, as well as many serious rare diseases.

"Biologics" are complex medicines that are manufactured using living cells, and are different from and far more complex than most traditional small molecule chemical drugs.   As intellectual property protections expire on the first generation of biological therapies, interest is growing in the development of copies of these innovative therapies, known in Canada as Subsequent-Entry Biologics (SEBs).

The patient safety and intellectual property issues associated with SEBs are complex, and the approval process for these products must be carefully considered through extensive consultation with patients and industry stakeholders.