Biologics and Biosimilars
July 2017
In preparation for the anticipated arrival of many biosimilars to the market in the next 24 months, Canadian pharmaceutical stakeholders have heightened their focus on biologics and biosimilars over the first half of 2017.
Provincial health agencies have begun formalizing their product-level positions on biologics and biosimilars. For example, the changes in late 2016 and early 2017 to infliximab reimbursement, which impacted originator biologic Remicade and biosimilar Inflectra in Alberta, British Columbia, Ontario and Quebec, highlighted broader questions about issues such as switching, interchangeability and pricing. Policy-makers continue to examine these key topics, as seen by the ongoing pCPA biologic/biosimilar consultations¹.
In the manufacturer community, the recently established Canadian Biosimilars Forum – a group of pharmaceutical manufacturer leaders in the biosimilar space including Amgen, Boehringer-Ingelheim, Coherus, EMD Serono, Merck, Pfizer, Sandoz and Teva – will certainly bring needed attention to industry-level topics and issues. The Forum is focused on maximizing the “positive impact of biosimilars on patients, on health systems and on the biosimilars industry itself”² in Canada.
In an industry with systems currently designed to manage the dynamics of innovator and generic products, many questions remain on the new and unknown operational challenges that will undoubtedly arise as biosimilars proliferate. What will the impact be on: procurement landscapes; hospital, retail and specialty pharmacies; and patient support programs? And will the value generated by these complex molecules offered at a lower price be enough to support the development of a sustainable model that will drive successful patient outcomes in therapeutic areas that require a high level of intervention, investment and management by health-care stakeholders?
We will surely see further engagement, leadership and innovation from all stakeholders in the coming months as the dynamics of biologics and biosimilars continue to evolve in Canada.
Essential Reading List:
New Canadian Forum Calls for Better Access to Biosimilar Medicines to Improve Health Care
Canadian Originator Biologics Coalition
Canada Attempts Biosimilar Balancing Act
CAHR MARKET ACCESS 201 Conference on June 13, 2017 with Panel 1 focusing on biosimilars
References
1 Bruce, F. “Canada Attempts Biosimilar Balancing Act,” Scrip Regulatory Affairs / Informa, (February 17, 2017).
2 “New Canadian Forum Calls for Better Access to Biosimilar Medicines to Improve Health Care [press release],” Canadian Biosimilars Forum, (2016).
http://www.newswire.ca/news-releases/new-canadian-forum-calls-for-better-access-to-biosimilar-medicines-to-improve-health-care-596664341.html