CADTH and BC Pharmacare move to ease entry of biosimilar drugs.

Posted on June 24, 2019

The Canadian Agency for Drugs and Technologies in Health (CADTH) and the Government of British Columbia have announced policy changes to facilitate public drug plan coverage for biosimilars.

According to Health Canada, a "biosimilar, is a drug demonstrated to be highly similar to a biologic drug that was already authorized for sale (known as the reference biologic drug)... Biosimilars are approved based on a thorough comparison to a reference drug and may enter the market after the expiry of reference drug patents and data protection... Health Canada evaluates all the information provided to confirm that the biosimilar and the reference biologic drug are similar and that there are no clinically meaningful differences in safety and efficacy between them. Once Health Canada authorizes a biosimilar for sale, a Notice of Compliance (NOC) and a unique Drug Identification Number (DIN) are issued." 

On May 23, 2019 CADTH announced that it will no longer review biosimilar drug submissions. Following approval by Health Canada, manufacturers will skip the HTA process and move directly to price negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA). On May 27, the Government of British Columbia also announced that it would be expanding coverage for biosimilars under its publicly funded PharmaCare program.

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