J. Bradley White, Nathaniel Lipkus
June 3, 2016
In an article which originally appeared in IAM Life Sciences 2016, J. Bradley White and Nathaniel Lipkus – Osler partners and members of the firm’s Intellectual Property practice group – examine the evolving issues related to the recent introduction in the Canadian marketplace of biosimilars, or highly similar versions of innovative biologic medicines. Though the potential cost-savings to patients and government-funded drug plans are well established, Canada has adopted a cautious approach to developing policies to permit approval and use of biosimilars.
This article reviews the current Health Canada regulatory regime governing the approval process for the use of biosimilars, including the initial guidance issued in 2010 and the subsequent draft guidance issued in 2015. The authors discuss the agency’s review of Inflectra (a biosimilar version of Janssen’s Remicade) and the ways in which Health Canada’s process differs from – and some would say lags behind – that of the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). The article also describes the patent pathway used by Health Canada for biosimilars and one biosimilar case that has been litigated through to hearing under the Patented Medicines (Notice of Compliance) Regulations – Amgen v. Apotex (2015 FC 1261). Finally, the authors consider the ongoing challenges biosimilar companies face in the marketplace, including receiving a recommendation from the Canadian Agency for Drugs and Technology in Health (CADTH) to be listed on provincial drug formularies, and comment on the future of this growing industry in Canada.
DOWNLOAD PDF: Biosimilars in Canada: at a tipping point
This article first appeared in IAM Life Sciences 2016, a supplement to IAM, published by Globe Business Media Group – IP Division. To view the guide in full, please visit IAM-media.com.