Biosimilars: The Quest for a Rational Regulatory and Intellectual Property Approach in Canada

Abstract

Biologics and biosimilars represent the promise for more effective treatments of many diseases. International treaty obligations influenced heavily by the biopharmaceutical industry and advanced through the international trade agenda may lead to an imbalance between incentivizing innovation and the public interest. Canada’s implementation of its obligations into national patent and regulatory laws encourages aggressive biologic patent protection strategies that, coupled with linked regulatory assessments, may establish compounding layers of exclusion that disproportionately disincentivizes both the biologics innovation and biosimilar development. This comparative analysis addresses the progression of international obligations and the way in which they have been implemented into Canada’s patent/IP and regulatory frameworks as compared to the US and EU. A quantitative comparison of biosimilar approvals and launches provides insight on how international obligations and national legislation have impacted these outcomes. Patent and regulatory laws must be balanced to incentivize innovation and promote access to treatments now and tomorrow.