The Forum believes that biosimilars can provide additional treatment options for physicians and patients while supporting the sustainability of the Canadian healthcare system once the originator biologic medicine has lost market exclusivity.
The Government of Canada’s Patented Medicines Pricing Review Board (PMPRB) estimated that public drug plans across Canada could save from $332M to $1.81B in the 3rd year following biosimilar entry across a portfolio of products. The actual savings will vary based on key policy decisions including:
- The listing status of biologic and biosimilar medicines
- The speed and spread of uptake
- The discount rate vs. the reference product
- The assertiveness of reimbursement policies
The savings from biosimilars create an opportunity to invest in new or expanded treatments and medical services while the drugs themselves offer similar clinical benefits to biologics in a more cost-effective way.
The Forum believes that without more proactive and assertive decisions by Canadian policymakers, this country will not have a robust biosimilars market.
Market data clearly shows that the uptake of biosimilars in Canada has so far been marginal and very slow, which minimizes the potential value that biosimilars offer. In order to create a long-term sustainable, competitive Canadian biosimilars market, there is an urgent need to implement appropriate, evidence-based policies that more directly and effectively expand access to biosimilars beyond what is currently available.
The Forum encourages payers to implement well-controlled switch strategies that support the one-time switch of an existing patient from a reference biologic drug to one of its biosimilars.
Switch strategies should be accompanied by engagement with multiple stakeholder groups and robust education programs.
Physicians have a key role to play in switching. After a reference biologic medicine has lost market exclusivity and biosimilars have become available, patients should return to their physician, who will prescribe a treatment from a list of approved biosimilars. Securing a new prescription is essential, since the Forum does not believe that reference biologics and biosimilars can be automatically substituted at the pharmacy level.
In Europe, there are 13 countries already supporting policies to switch patients from a reference biologic medicine to its biosimilar.
Health Canada says that it “considers a well-controlled switch from a reference biologic drug to a biosimilar in an approved indication to be acceptable, and recommends that a decision to switch a patient being treated with a reference biologic drug to a biosimilar, or between any biologics, be made by the treating physician in consultation with the patient and take into account any policies of the relevant jurisdiction.”
Health Canada also says that “no differences are expected in efficacy and safety following a change in routine use between a biosimilar and its reference biologic drug in an authorized indication.”
