Canada Updates Biosimilar Guidance On Reference Drug, Extrapolation, Scientific Advice
This article was originally published in SRA
Executive Summary
Companies wishing to comment on Canada's new draft guideline on biosimilar medicines have four weeks to do so before the consultation period closes on Feb. 151. The guideline, which updates the existing guidance, includes new information in areas like extrapolation and the choice of comparator drug, as well as a section on a biosimilar scientific advice pilot that began in September last year2.