Biosimilars Make Progress in the Canadian Market, but Stakeholders See More Work Ahead

While much attention over the past few weeks has been on the US biosimilars market, with its recent approvals and product launches, Canada has also been making strides in its own biosimilars experience.

First, biosimilars of infliximab appear to be eroding the brand-name Remicade’s hold on the market in the Canadian province of Quebec. According to a Reuters analysis of government data, biosimilar infliximab options, primarily Inflectra, gained 11.4% of market share in January of this year, up from just 0.7% in February of 2017. By August 2019, 13.4% of infliximab-treated patients in Quebec were receiving a biosimilar.

Notably, biosimilars’ market share gains came despite the fact that, in February of 2019, a Quebec court ordered the province to restore full coverage of the brand-name drug after Quebec had previously determined it would reimburse only the biosimilar, saying that Janssen had not been given appropriate notice when the province changed its coverage.

Additionally, in Ontario, the province’s Ministry of Health and Long-Term Care has proposed a regulatory amendment that, if approved, would reduce requirements for biosimilar drug submission to both simplify them and align them with Health Canada’s national processes.

Currently, Health Canada has an comprehensive approval process to determine whether there exist clinically meaningful differences between biosimilars and their references, and the amendment would allow Ontario to rely on Health Canada’s approval without requiring drug makers to submit evidence of safety and efficacy to the province, thereby reducing duplicative work.

Ontario’s proposed amendment comes after a 2018 change to the procedure used by Canadian Agency for Drugs and Technologies in Health (CADTH), the Canadian entity responsible for health technology assessments.

The revised procedure reduced the number of submission requirements that manufacturers must meet when submitting a biosimilar summary dossier to provide relevant information for a biosimilar product for the pan-Canadian Pharmaceutical Alliance and participating Canadian jurisdictions to make decision about which products to include in their drug plans. The change, said CADTH at the time, was expected reduce biosimilar review timelines from 6 months to 3 months.

However, there remains room for Canada to improve its uptake of biosimilar medicines; this month, in a paper published in BMC Health Services Research, authors from universities in Saskatoon and Alberta report that there is significant potential in terms of cost savings that could be realized through biosimilar use in Canada, and they say that there will need to be new policies to prioritize biosimilar use.¹

In the retrospective analysis, the researchers found that, from July 2016 to June 2018, the purchase of biosimilars of infliximab, insulin glargine, and filgrastim in each Canadian province varied widely, and ranged from a low of just 0.1% to a high of 81.6%. If biosimilars had been used in 100% of cases over the 2 years studied, CAN $1,048,663,876 (approximately US $793,513,468) could have been saved.

Infliximab, they find, would account for the greatest proportion of savings, and even if a biosimilar was used in only 80% of eligible cases, biosimilar infliximab would have generated CAN $838 million (approximately US $634 million) over the 2-year period.

As more biosimilars become approved for use by Health Canada, say the authors, new policies to prioritize biosimilar use will be needed if the nation is to reap major cost savings for patients and payers.

Reference

1. Mansell K, Bhimji H, Eurich D, Mansell H. Potential cost-savings from the use of biosimilars filgrastim, infliximab and insulin glargine in Canada: a retrospective analysis. BMC Health Serv Res. 2019;19:827. doi: 10.1186/s12913-019-4680-2.