As of June 30, Health Canada had approved 16 biosimilars, based on 11 comparator products (3 in 2019).
Market Access: On January 16, the Quebec Court of Appeal overturned the Minister's decision to delist REMICADE from Quebec's Liste des médicaments for violating procedural fairness. British Columbia announced in May that it will provide funding for further biosimilars and, as of November 25, will no longer provide coverage for three original biologics for certain indications, except in exceptional cases, effectively requiring a change to the corresponding biosimilar(s).
Naming: On February 14, Health Canada released its Policy Statement on the Naming of Biologic Drugs, which states that “biologic drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix.” Further, both the brand and non-proprietary names should be used throughout the medication use process so that brand names can distinguish amongst biologics having the same non-proprietary names.
Studying Usage: The pan-Canadian Pharmaceutical Alliance and Cancer Care Ontario have partnered to create a pan-Canadian Oncology Biosimilars Initiative, which aims to ensure appropriate implementation and cost-effective use of therapeutic oncology biosimilars across Canada. In February, the PMPRB released its 2017 edition of Meds Entry Watch which includes an analysis of the availability, pricing and uptake of biosimilars approved by the Food and Drug Administration (FDA), European Medicines Agency and/or Health Canada between 2006 and 2017. In March, Health Canada announced that it is collaborating with the Drug Safety and Effectiveness Network on a project studying patients with inflammatory rheumatic diseases and inflammatory bowel disease who are taking biologic drugs to compare the safety and effectiveness of biosimilar drugs to the reference biologic drug.
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