Letter to Health Canada regarding proposed changes to biosimilar drug approval processes
Release Date: 09/08/2025 Staff Reference: Joan WeirThe CLHIA has submitted feedback to Health Canada regarding proposed changes to biosimilar drug approval processes. Representing insurers that provide prescription drug coverage to 27 million Canadians, the CLHIA supports Health Canada's move to prioritize quality assessments over domestic clinical trials. This shift could accelerate market access for biosimilars, reduce costs, and align Canada with international standards.
We recommend robust post-market surveillance to manage risks, including real-world evidence tracking and enhanced data-sharing with global regulators. The association also questions the need for separate submissions when biosimilars seek minor new indications not approved for the originator.
The CLHIA welcomes the revised guidance and encourages early dialogue between Health Canada and biosimilar manufacturers to ensure clarity and efficiency in the approval process.
