Fact Sheet: What Can Canada Learn from the European Biosimilar Experience?

canadasubstitutionfactsheet
Click to View the Fact Sheet

The undisputed leader in biosimilars with more than 60 products approved and the largest biosimilar market in the world, Europe has achieved impressive biosimilar uptake rates. These can be as high as 91% for older products (before the approval of the first monoclonal antibody biosimilar in 2013) and up to 43% for newer products (approved post-2013).

As Canadian provinces including British Columbia and Alberta look to duplicate Europe’s success, ASBM has prepared this fact sheet to serve as a resource.

The fact sheet contrasts the principles that Europe has embraced- which include preserving physician/patient choice, promoting competition between multiple products, and prohibiting automatic substitution- with the forced-switching policy announced by the government of British Columbia – and is being considered by other provinces.

B.C. Health Minister Adrian Dix cited Europe’s high biosimilar uptake rates as a justification for the [forced-switching] policy, but disregards the path and principles that led to Europe’s success:

  • It was not accomplished through a reimbursement ban on originator biologics, i.e., the limitation of medicine choice and resulting forced-switching mandates.
  • Instead, cost reductions were achieved by preserving choice for physicians and patients and promoting competition between all approved products based on many factors including cost, clinical evidence, delivery mechanism, patient history, and other factors.
  • In nearly every European country, automatic substitution of biologic medicines is not permitted.
  • Not only does the B.C. policy have no analogue among Western European countries, it is built upon principles Europe has overwhelmingly rejected.

European physicians have had 13 years of experience with biosimilars, and thus have high familiarity and confidence in them.

  • Yet the majority (57%) are opposed to switching their patients to a biosimilar for non-medical (cost) reasons.
  • They even more strongly oppose (73%) a third-party initiated non-medical switch of their patients’ biologic medicines, as occurs in the British Columbia policy, and which other  provinces are considering. 

ASBM’s 2017 survey of Canadian physicians showed similarly strong opposition (64%) to the third-party switching of stable patients for non-medical (e.g. cost) reasons.

 Canadian physician groups and patient advocacy organizations have also raised concerns raised with the BC forced-switching policy.

Click here to read the fact sheet.