Canada has eliminated a Phase III trial requirement for biosimilar approvals, according to the report. The policy change comes as the U.S. FDA also proposed to substantially eliminate the need in a draft guidance released in October 2025. The biosimilar regulatory shift matters for developers because Phase III studies can be a major time-and-cost barrier to bringing follow-on biologics to market. Changes to evidentiary expectations could speed development timelines and affect how companies plan study design and comparability packages. For manufacturers and payers alike, accelerated biosimilar entry can influence competition, pricing dynamics, and patient access across biologic-heavy therapeutic areas.