Author byline as per print journal: Michael S Reilly, Esq; Jane Barratt, PhD Introduction: The first biosimilar entered the Canadian market in 2009 and the first ophthalmic biosimilar was approved in 2022. In 2022, the Alliance for Safe Biologic Medicines (ASBM) and the International Federation on Ageing (IFA) asked prescribing ophthalmology physicians in Canada for […]
Author byline as per print journal: Professor Philip J Schneider1, MS, FASHP, FASPEN, FFIP; Michael S Reilly2, Esq Canada has approved a total of 36 biosimilars. While the approval of biosimilars is regulated at the national level, decisions about biosimilar substitution are made at the provincial level. Four Canadian provinces, representing around 50% of the […]
Abstract: Biological molecules represent a significant portion of therapies utilized in Canada. Biosimilars, also known as subsequent entry biologics (SEBs) in Canada, are highly comparable versions of the originator products. Over the next few years, a number of patents for innovator biologicals will expire in Canada and this creates a tremendous opportunity for the entrance […]
Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Eleonora Allocati4, BSc, MSc; Evelien Moorkens5, BSc, MSc Abstract: Siu et al. comprehensively assessed the rapidly changing regulation and reimbursement environment for biologicals and biosimilars in Canada and the resultant implications. The current situation in Canada is compared with similar initiatives across different countries to […]
Abstract: The principles Health Canada use when extrapolating the indications and uses of a biosimilar product subsequent to a single clinical trial or limited number and scope of clinical trials during product development are discussed. The principles underlying the regulatory framework for subsequent entry biologics (SEBs or biosimilars) in Canada explain the position taken by […]
Abstract: This paper provides a detailed comparison of biosimilars guidelines issued in Canada, the European Union, Japan and Korea; and by the World Health Organization (WHO). This comparison highlights the need for harmonization of global regulatory standards for the approval of biosimilars. Biosimilars are recognized around the world as safe and effective medicines. Despite this […]
