Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges

Author(s): Agnes V Klein, MD, DPH, Jian Wang, MD, PhD, Ally Pen, PhD

Abstract: Biologicals have offered a new avenue for targeting therapy to treat life-threatening and chronic diseases. The recent or pending patent expirations of many successful biologicals have permitted the marketing of ‘copy’ versions of the off-patent biologicals, generally known as biosimilars (subsequent entry biologics in Canada). The reduced clinical package and the potential for extrapolation […]

Read more →