Insight Series: Biosimilars in Canada
The desire for sustainability of public and private drug plans, and the rapid growth of high-value biologics that are going off-patent, has created a significant opportunity for biosimilar products in the Canadian market. In 2016, growth in the biologics category outpaced the total Canadian market (+9.5% versus +3.2%), resulting in continued interest in biosimilars as a cost reduction tool.1 However, launching a biosimilar in Canada presents unique and nuanced regulatory and reimbursement challenges. This article aims to provide an update on the current situation in the Canadian biosimilar market access space.
Current Canadian Biosimilar MarketThere are six biosimilar agents approved in Canada at this time: Omnitrope® (somatropin) was the first biosimilar to market in 2009; Inflectra® (infliximab) was launched in 2014; Basaglar® (insulin glargine) and Grastofil® (filgrastim) followed in 2015; and the etanercept biosimilars Brenzys® and Erelzi® were launched in 2016 and 2017, respectively.
Switching from an innovator biologic to a biosimilar is currently influenced by different stakeholders in Canada. Although Health Canada does not have authority in the area of switching, it has a position that suggests that well-controlled switches in an approved indication are acceptable based on a decision made by a physician in conjunction with their patient, that also factors in clinical evidence and any applicable policies.2 However, the decision-making process is increasingly influenced by public and private payers. This is evidenced by the fact that nine out of ten provincial payers preferentially reimburse the biosimilar Inflectra® for infliximab-naïve patients.
The uptake of biosimilars in Canada has been modest due in part to a lack of formal switching guidelines; limiting biosimilars to treatment-naïve patients; availability of more robust originator-funded patient support programs; and some initial reluctance amongst physicians and patients. However, the tide may turn as public payers increasingly adopt preferential reimbursement strategies to support sustainability, and the perception of biosimilars evolves.
Biosimilar Regulatory and Market Access Update
Health Canada: Biosimilars are regulated as new drugs by Health Canada, and they are subject to the same regulations as innovative products. However, for biosimilars, flexibility in the current framework allows Health Canada to regulate biosimilars based on demonstrated similarity, leading to the requirement of a reduced biosimilar clinical and non-clinical data package. A new guidance document that details the regulations for biosimilars was released by Health Canada in November 2016: Information and Submission Requirements for Biosimilar Biologic Drugs.3 Changes contained in the guidance document include: ability to use a non-Canadian sourced reference drug in the submitted comparative studies; acceptability of the data package without a clinical efficacy trial providing there is a clinically relevant pharmacodynamics endpoint; and revised wording to clarify the requirements and decision-making process when biosimilar manufacturers request approval for a further indication without doing specific studies. As an important first step, Health Canada encourages biosimilar manufacturers to meet with Health Canada early to obtain regulatory guidance in advance of New Drug Submission (NDS) filing. The new guidance document contains information on how to request biosimilar scientific advice and pre-Clinical Trial Application consultation meetings.
Health technology assessment (HTA): Like innovative products, biosimilar drug listing on a public drug plan will require an HTA by one of the Canadian Agency for Drugs and Technologies in Health (CADTH) programs: the Common Drug Review (CDR) for non-oncology drugs and pCODR for oncology drugs (excluding the province of Quebec); or Institut national d’excellence en santé et en services sociaux (INESSS) for the province of Quebec. In 2014, CADTH published a report, Common Drug Review Procedure and Submission Guidelines for Subsequent Entry Biologics to guide manufactures on the submission requirements and process for biosimilars.4 During subsequent developments, CADTH has an objective to streamline the biosimilar HTA process to align reviews more closely with Health Canada so that the regulatory approval, the Notice of Compliance, and the HTA recommendation from CADTH are issued at, or close to, the same time, thereby reducing the time needed to attain public reimbursement. As a starting point, CADTH has completed consultations with stakeholders toward a revised abbreviated submission and review process for biosimilars, and presented an overview of the proposed biosimilar process in October 2017.5 CADTH has advised that changes to the process will likely occur in early 2018.
INESSS has also revamped their biosimilar submission process by adding in a checklist specific to biosimilars.6
pan-Canadian Pharmaceutical Alliance (pCPA): Submission to the pCPA, a coalition of public payers that negotiate price on behalf of the provincial, territorial and federal Ministries of Health and cancer agencies, is the next step in the biosimilar public market access pathway. In April 2016, the pCPA provided guidance to manufacturers with the First Principles on Subsequent Entry Biologics7, a framework to support a more consistent approach to negotiation of biosimilars. The pCPA continues to consult with innovator and biosimilar manufacturers with a goal to produce a more consistent, transparent, and predictable negotiation process. To date, pCPA negotiations have been completed for Inflectra (rheumatoid arthritis and gastrointestinal indications), Grastofil, Basaglar, Brenzys, and Erelzi.
Private payers: The use of biosimilars as a cost reduction tool varies among private payers. Strategies can range from delisting the originator brand, preferential reimbursement of the biosimilar for all treatment-naïve patients, and provision of choice to their plan members, to product listing agreements (PLAs) with the originator. However, most private payers have been quite conservative in their adoption of biosimilars, looking first to changes in approach by public payers, and shifting decision-making to physicians, employers or benefit consultants.
Regulatory and Market Access Timeline: The pathway to gain biosimilar market access in Canada can vary from 12 to 18 months for private payers, to roughly 21 to 27 months for public payers (Figure 1). With the proposed streamlining of the CADTH processes in 2018, it is expected that the time to public market access will decrease.
See Figure 1 below for a timeline of the market access pathway in Canada.
- IQVIA, Canadian Drugstore and Hospital Audit, MAT December 2016.
- Fact Sheet: Biologics [Internet]. In: Drugs and health products. Ottawa: Health Canada; 2017 [cited 2017 December 11]. Available here. (broken link)
- Guidance document: information and submission requirements for biosimilar biologic drugs [Internet]. In: Drugs and health products. Ottawa: Health Canada; 2016 [cited 2017 Dec 11]. Available here.
- Canadian Agency for Drugs and Technology in Health (CADTH). Common Drug Review procedure and submission guidelines for subsequent entry biologics, March 2014 [Internet] Accessed 2017 Dec 11. Available here.
- Canadian Agency for Drugs and Technology in Health (CADTH). CADTH drug portfolio information sessions, October 2017 [Internet] Accessed 2017 Dec11. Available here.
- Institut national d’excellence en santé et en services sociaux (INESSS). Registration application [Internet] Accessed 13 Dec 2017. Available here.
- Pan-Canadian Pharmaceutical Alliance. Subsequent Entry Biologics (SEBs) First Principles [Internet]. Accessed 2017 Dec 11. Available here.
This is the first in a series of articles provided by Innomar Strategies to update manufacturers on relevant changes and new information in the specialty pharmaceutical marketplace.