Uptake of biosimilar drugs in Canada: analysis of provincial policies and usage data.

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From: CMAJ: Canadian Medical Association Journal(Vol. 194, Issue 15)
Publisher: CMA Impact Inc.
Document Type: Report
Length: 3,140 words
Lexile Measure: 1950L

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Biologics represent a large segment of drug spending in Canada: although they constituted just 1.5% of prescription volumes, biologics accounted for 27.3% of expenditures in 2018. (1) As of 2018, the price of biologics in Canada, including spending per capita, was second only to that in the United States among the Organisation for Economic Cooperation and Development (OECD) countries. (2) For example, Canada has spent more on anti-tumour necrosis factor (anti-TNF), a class of biologic drug, than on any other publicly covered medicine. (3) Over the last 10 years, Canada has seen a threefold increase in spending on biologics, and this spending will continue to grow. (4)

With more than 1000 biologic drugs marketed in Canada and biologics now used in most clinical specialties, the need to achieve cost savings is of critical importance. (5) Biosimilars--agents with similar efficacy and safety to originator drugs--offer an important avenue for cost savings. (1,4,6,7) Yet, presently only 31 biosimilars are approved for use in Canada, less than half the number available in the European Union, and the use of biosimilars in Canada is relatively low. (5,8)

We evaluated the current state of biosimilar policies and use across Canada, highlighting 3 illustrative cases--insulin glargine, infliximab and etanercept. We briefly discuss interchangeability and indication extrapolation before making suggestions for enhancing the market through harmonization of biosimilar policies, patient and prescriber education, and manufacturer collaboration.

What is the policy context of biosimilars in Canada?

Although more than 30 biosimilars have been approved in Canada, uptake has been much lower than that of conventional generics. (1,9) The Canadian policy framework for some of the earliest available biosimilars (i.e., infliximab, etanercept and insulin glargine) provides important insight into the foundation of the marketplace for these products.

Biosimilar infliximab and etanercept

The first iteration of the anti-TNF agent infliximab entered the Canadian market in 2001; in 2014, the earliest approved biosimilar infliximab (Inflectra) was marketed. (5) By September 2015, the Canadian Agency for Drugs and Technologies in Health (CADTH)'s Common Drug Review published a review endorsing Inflectra for listing with similar criteria to the innovator.10 Shortly thereafter, British Columbia and Ontario listed biosimilar infliximab on their formularies for those who were starting infliximab for the first time ("new start policies"; Table 1).

Another anti-TNF drug (etanercept) had 2 biosimilar products approved in 2016 (Brenzys) and 2017 (Erelzi). (5) As with infliximab, CADTH's report endorsed Erelzi for patients in whom etanercept was considered a necessary therapy under similar reimbursement criteria to the originator. (10) Under new start policies, biosimilar etanercept was incorporated into provincial formularies beginning in July 2017 with BC and Prince Edward Island. It was not until 2019 that Canadian provinces began implementing policies that required patients receiving treatment to switch to the biosimilar to maintain public drug coverage.

Biosimilar insulin glargine

Long-acting insulin glargine was first approved in 2002; in 2015, a single biosimilar was authorized for sale. (5) In the same year, biosimilar insulin glargine was endorsed by the Common Drug Review and was included on...

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Gale Document Number: GALE|A700407656