Canadians pay higher prices for pharmaceuticals than any other country except the USA and a trade agreement with Europe is likely to inflate drug prices still further. But access to costly drugs like biologics also varies geographically within Canada, as each individual province controls its own formulary and has different funding priorities. As many as 10% of Canadians cannot afford to fill prescriptions and even those with private insurance have no guarantee that a particular product will be covered. In Canada, biosimilars (which were initially known as ‘subsequent entry biologics’ [SEBs]) are approved under regulations established by Health Canada in 2010 and updated in 2017.
|"The evidence clearly shows that most private drug plans – that provide coverage to 19 million Canadians – are not sustainable in the long term. The biggest threat is the skyrocketing cost of new biologic and specialty drugs." 3
||"I can't tell you how many times I'd have to go into the sample drawer, because I knew that if I gave a prescription to someone, they weren't going to fill it because they couldn't afford it." 4 Eric Hoskins MD
Because there are dozens of different purchasers for the same drugs – private employer plans, public plans and hospitals – Canada is not able to pool its purchasing power and buy drugs in bulk, which would allow negotiation of lower prices. In the face of steadily rising drug costs, many agree that the best solution would be the creation of a government-run program of ‘universal pharmacare.'4,5
In the meantime, Canadians pay 20% more for patented drugs compared to France or the UK, amounting to an extra CDN $2.1 billion a year.6 An estimated 1 in 10 Canadians can't fill prescriptions because of the expense4 and are at the mercy of their provincial or territorial government’s decision to make important medications easily available to those who need them most. Canadians with chronic conditions like rheumatoid arthritis or inflammatory bowel disease have unequal access to biologics which are internationally recognized as ‘standard of care.’7,8 And for the huge numbers of Canadians living with diabetes, the greatest challenge is affordability and access to diabetes medications, devices and supplies, which varies widely across the country.9
|"57% of Canadians with diabetes indicate that they do not comply with their prescribed therapy due to the cost of medications, devices and supplies. Only half of Canadians with type 2 diabetes have their blood glucose levels under control, and the majority of patients incur adverse health conditions." 9
In Canada, biosimilars were originally known as subsequent entry biologics (SEBs). In March 2010, Health Canada issued its first guidelines for SEBs harmonized with the strict regulatory process used by the EMA. In early 2017, Health Canada’s regulatory guidance was updated. In the interests of international alignment, the term ‘biosimilar’ was officially adopted. Other aspects of the revised guidance reflect Canada’s unique approach to biosimilar regulation:
As with small molecule generics, policies regarding the substitution of biosimilars are determined by provinces and territories. However, Health Canada has actively cautioned against allowing the substitution of biosimilars and it seems likely that regional governments will follow federal policy.10
An up-to-date record of biosimilars approved in Canada can be found here.
A study by the Canadian Society of Nephrology found that switching to a biosimilar of epoetin could save $35–50 million a year in Canada, with cumulative savings of $221 million after 5 years (2015–2019).13
Patent expiries for leading biologics are typically later in Canada than in Europe or the USA and may be delayed further by CETA.1 However, biosimilar development programs are well underway in Canada and, as in the USA, many innovator biologic companies are positioning themselves to benefit either way by creating their own biosimilar portfolio.