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July 19th, 2022
Canadian Ophthalmological Society (COS) Position Statement on Biosimilars
Biosimilar biologic drugs (or biosimilars*) were introduced in the Canadian market in 2009, however, the first ophthalmic biosimilar is expected to be launched in Canada in the fall of 2022. With the advent of biosimilar drugs into the Canadian market payors (government and insurers) are developing policies on how these medications are integrated into reimbursement programs for existing “innovator” or reference drugs. The trend currently seems to be toward limiting or restricting physician and patient choice in incorporating biosimilars into the Canadian market.
This seems contrary to the European experience where forced substitution has not been necessary to encourage uptake and realize significant savings.
The physician-patient relationship and a patient’s resulting confidence in their treatment plan is crucial to successful treatment. Limiting choice and mandating changes to existing successful treatment regimens undermines that confidence and could be detrimental to patient care.
In addition, given the unique immunological environment and limited tolerance for inflammation which exists with direct administration of the medication into the eye, the COS cautions against mandating large scale, automatic shifts from the reference to biosimilar medications until sufficient human experience has been accumulated to ensure confidence in safety. Furthermore, as individual patient response to medication varies, physicians must have the opportunity to switch back to the original medication if problems develop in order to prevent harm.
The COS welcomes and supports the potential of biosimilars to expand the choices available for effective treatment of eye disease in a cost-effective manner, however it is vital that payors and payor’s policies do not constrain medical choice or undermine patient confidence in treatment plans.
Created June 2022
*A biosimilar biologic drug, or biosimilar, is a biologic drug that is highly similar to a qualifying biologic drug that was already authorized for sale (known as the reference biologic drug). (Health Canada, Handbook for healthcare professionals on biosimilar biologic drugs, https://www.canada.ca/en/health- canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/biosimilar- biologic-drugs/handbook-healthcare-professionals.html#Biosimilar_Drugs accessed June 27, 2022)