The Canadian Agency for Drugs and Technology in Health (CADTH) are revising the regulatory process for biosimilars. Following a period of consultation, CADTH has streamlined the assessment process for biosimilars, with shorter approval timelines, fewer submission requirements and abbreviated biosimilar dossier templates. The overall review timeline for biosimilars will be cut in half to three months, with fees also reduced.

Reference: Canada cuts assessment times.Generics Bulletin,2018;344:9