Health Canada’s 2017 Biosimilars Workshop: Summary Report
On March 20, 2017, Health Canada hosted a workshop on biosimilars. The objectives of the workshop were to educate stakeholders on the federal regulatory approach to biosimilars following release of the updated Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs, and to facilitate dialogue between organizations that contribute to biosimilar access in Canada. More than 60 stakeholders participated in the workshop, representing a broad and diverse range of decision-makers from across the authorization to access spectrum. Participants included representatives from health technology assessment, pricing, formulary listing and reimbursement, physician, pharmacist, patient, and industry organizations as well as Health Canada's Biologics and Genetic Therapies Directorate (BGTD), Marketed Health Products Directorate (MHPD), and Strategic Policy Branch (SPB).
- A competitive and sustainable market for biosimilar and innovator drugs could offer many benefits to the healthcare system, including broadening access to effective biologic treatments, reducing the cost burden and enabling savings to be re-directed across all areas of healthcare including funding of new innovative therapies.
- Health Canada's rigorous requirements for authorization serve to ensure that biosimilars authorized in Canada meet the same high standards for quality, safety and efficacy as all other biologic drugs. Because there are no clinically meaningful differences in safety and efficacy between a biosimilar and its reference biologic drug, healthcare professionals and patients can be confident of clinical outcomes when using a biosimilar authorized in Canada.
- Despite their potential benefits, there has been low uptake of biosimilars in Canada to date. Providing unbiased education and information to relevant stakeholders may help to increase confidence in biosimilars.
- Policies regarding switching from a reference biologic drug to a biosimilar should consider the need for costs savings as well as patient and physician choice.
- Policies and position statements on biosimilars are evolving to reflect increasing experience with and confidence in biosimilars as a treatment option.
The day started with welcoming remarks from Pierre Sabourin, Assistant Deputy Minister of Health Canada's Health Products and Food Branch. Mr. Sabourin spoke to the key role that biosimilars play in the federal government's priority of improving access to necessary prescription medications. Mr. Sabourin also highlighted the potential opportunity provided by biosimilars to enhance treatment options, strengthen the supply chain and provide cost savings.
The agenda was organized into five sessions focused on different themes. Each session began with presentations from experts within their field and concluded with an informal discussion between presenters, additional panelists and audience members.
Session I: Regulatory Overview of Biosimilars
This session began with a presentation on Health Canada's regulation of biosimilars from Dr. Anthony Ridgway, Acting Director of the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics at BGTD. Dr. Ridgway provided an overview of Health Canada's pre-market regulatory review and post market surveillance processes, and outlined the differences between an innovator biologic development program and a biosimilar development program. In an innovator biologic development program, the sponsor must independently demonstrate the quality, safety and efficacy of a therapeutic product. For biosimilars, the purpose of the development program is to demonstrate similarity between the biosimilar and the reference biologic drug and to show that there are no clinically meaningful differences between them. The foundation of a biosimilar development program is based on extensive side-by-side structural and functional characterization of the biosimilar and the reference biologic drug to demonstrate similarity, with comparative clinical studies to rule out any differences in safety and efficacy. Dr. Ridgway described the totality of quality, non-clinical and clinical evidence that serves to ensure that biosimilars authorized by Health Canada meet the same high standards for safety and efficacy as all other biologic drugs.
Dr. Ridgway also outlined the post-market surveillance requirements for biosimilars, which are considered to be "stand alone" products once authorized and must meet the same pharmacovigilance requirements as all other drugs. Dr. Ridgway concluded his presentation with a list of resources on biosimilars available on the Health Canada website including the Biosimilars Landing Page, Biosimilars Fact Sheet, and the Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs.
Catherine Parker, the Director General of BGTD, followed with a presentation on "hot topics" that fell outside the scope of the biosimilars guidance document but are of significant interest to numerous stakeholders. Ms. Parker spoke to the value of Health Canada's collaborations with international regulators and organizations in keeping pace with ongoing biosimilar scientific and regulatory developments. Ms. Parker made a clear distinction between switching and interchangeability: Switching generally refers to a one-time change from a reference biologic drug to a biosimilar, whereas, in Canada, interchangeability often refers to the ability for a patient to be changed from one drug to another equivalent drug by a pharmacist without the intervention of the doctor who wrote the prescription. Ms. Parker further stated that Health Canada considers a well-controlled switch from a reference biologic drug to a biosimilar in an approved indication to be acceptable, and recommends that a decision to switch a patient being treated with a reference biologic drug to a biosimilar, or between any biologics, be made by the treating physician in consultation with the patient and take into account any policies of the relevant jurisdiction.
Naming of biologic drugs and biosimilars and evaluation of the need for a unique suffix or qualifier is another area of high interest to stakeholders, and Ms. Parker signalled Health Canada's intent to consult with stakeholders to understand the impact of naming on Canadian prescribing, dispensing and pharmacovigilance needs. Ms. Parker addressed the need to build confidence in biosimilars as a treatment choice, emphasizing that healthcare professionals and patients should be confident in using biosimilars authorized by Health Canada since their quality, safety and efficacy are highly similar to that of the reference biologic drug with no clinically meaningful differences between the two products. Finally, Ms. Parker sought input from workshop attendees on what additional information they would like to see from Health Canada.
Session I concluded with a discussion between audience members and a panel of Health Canada regulatory experts that included topics such as naming, switching, and interchangeability.
Session II: Current State of Biosimilars
The second session began with a presentation from Frances Hall, Director of Health Canada's Strategic Policy Branch (SPB), who provided an overview of international policies and initiatives seeking to promote awareness and uptake of biosimilars in countries including Australia, the UK, Norway, Germany and France. She introduced the concept of gainsharing, in which cost savings from the use of biosimilars can be reallocated to improve overall health system outcomes.
Elena Lungu from the Patented Medicine Prices Review Board (PMPRB) followed with a presentation on potential savings from biosimilars in Canada. She presented evidence that biosimilars may offer substantial savings opportunities in Canada depending on the timing of biosimilar market entry, their uptake and price discount. However, at current Canadian price discounts for biosimilars and average uptake, estimated potential savings in the third year following biosimilar market entry would be limited to approximately 8% or just tens of millions of dollars for top-selling biologics. In comparison, higher price discounts and uptake could result in savings of hundreds of millions of dollars.
Jody Cox from Biosimilars Canada, an association representing biosimilar manufacturers, presented a biosimilars industry perspective. She stated that recent updates to Health Canada's guidance document on biosimilars have increased alignment with leading international regulatory authorities and have reduced the regulatory burden for sponsors. However, she stated that the potential for biosimilar savings is not yet being realized in Canada, with just under $13 M in sales in 2015 for all 5 biosimilars marketed in Canada. She spoke of some of the challenges that the biosimilar industry faces in Canada, including delays between authorization and formulary listing due to health technology assessment (HTA) and price negotiations, and the added expense of patient support programs in Canada. She called for proactive policies and ongoing education of key stakeholders including patients and physicians to increase biosimilar uptake.
Jennifer Chan from the Canadian Biosimilars Forum, another association representing biosimilar manufacturers, presented a second biosimilar industry perspective. She spoke to the opportunity that biosimilars present for patients, health care professionals and a sustainable public drug system, the need for a competitive and sustainable biosimilar market, and how savings from biosimilars could, in turn, lead to investment in new innovative therapies. She also spoke to the core challenges faced by the biosimilars industry, including misconceptions and confusion about biosimilars among patient groups and clinicians, a slow and inefficient reimbursement process, and the need for new policies in Canada to support implementation and uptake of biosimilars. She called for stakeholders to work together to improve biosimilar uptake, streamline regulatory and HTA processes, and educate stakeholders on the safety and efficacy of biosimilars approved for use in Canada.
This session's panel discussion focused on the potential for gainsharing across the health system, the potential for lower prices to increase access for Canadians who do not have prescription drug insurance or who are underinsured, the role that innovator companies have to play in discussions on cost-saving, and the need for education on biosimilars from healthcare professional associations.
Session III: Pricing and Reimbursement for Biosimilars
Marina Richardson from the Canadian Agency for Drugs and Technologies in Health (CADTH) presented the CADTH Common Drug Review process for biosimilars and provided an overview of their experience to date with the process. She spoke of the current HTA assessment process for biosimilars, and the challenges associated with it compared to HTA assessment of an innovator biologic drug.
Simon Lee from the pan-Canadian Pharmaceutical Alliance (pCPA) stated that the pCPA's national price negotiation process for biosimilars is no different from that for innovative drugs. He commented on the pCPA's First Principles for Subsequent Entry Biologics (biosimilars) released in April 2016, and stated that he expects these to evolve as the pCPA engages with stakeholders to develop a more comprehensive biosimilars policy framework. Consultations on the pCPA principles are starting in March 2017.
Brad Alyward from the Nova Scotia Department of Health and Wellness presented a general public payer's perspective on biosimilars, with the caveat that approaches to biosimilars differ across Canada's provinces and territories. He stated that public payers are under significant budget pressure as fewer generic drugs are being introduced yet many new drugs are under review. Biosimilars represent an opportunity for public payers to reinvest savings in order to fund new drugs. However, significant uptake and savings due to biosimilars has not been achieved to date. Public payers are looking to improve the efficiency of their processes and to prioritize drugs which offer the greatest benefit.
The discussion panel at the conclusion of Session III covered authorization of indications using extrapolation, a call for more transparency regarding the pCPA and provincial listing processes, and concerns from patients at the potential prospect of being forced to switch from a reference biologic drug to a biosimilar for non-medical reasons. The discussion also included the importance of HTA of biosimilars to the provinces, territories, and pCPA, and how HTA processes could be better tailored for biosimilars.
Session IV: Perceptions and Perspectives on Biosimilars
Dr. Carter Thorne from the Canadian Rheumatology Association (CRA) discussed how treatment options for patients with inflammatory joint disease have evolved over time, with 33% of patients who are currently treated by a rheumatologist taking a biologic, and the increasingly high cost of specialty drugs for inflammatory diseases. He presented the CRA's 2013 Position Paper on the Establishment of a Common Drug Review (CDR) Procedure and Process for Reviewing Subsequent Entry Biologics (biosimilars), as well as an updated draft CRA Position Statement on Biosimilars which is under review for potential endorsement by several professional rheumatology organizations. Updates being considered for endorsement include a statement that there may be interchangeability between a biosimilar and a reference biologic drug in an individual naïve to the molecule; however, interchangeability for patients on established therapy is not supported at the present time.
Mario Bédard from the Canadian Society of Hospital Pharmacists (CSHP) described the process for drug funding in hospitals, which is separate from that of provincial drug plans. The hospital drug budget is part of the global hospital budget, thus hospital drug costs impact the funds available for other types of hospital services such as surgeries. He also spoke to the need for continuity of care between medications available in the hospital and those available in the community before or after patient admission.
Dawn Richards from the Canadian Arthritis Patient Alliance (CAPA) shared her personal experience with arthritis, as well as the uncertainties that arthritis patients face as to the future course of their disease. She emphasized that the first expert in a disease is the person living with that disease, and that people with diseases have the right and responsibility to be included in the policy, health care and research decisions related to their health and quality of life. She outlined CAPA's positions on areas including substitution, interchangeability, switching, naming, pharmacovigilance and patient support programs. She spoke to areas where there is broad agreement between the views of various patient groups, and other areas, such as switching, substitution and interchangeability, where there are differences in positions between patient groups.
The panel discussion between audience and presenters, as well as Mina Mawani of Crohn's and Colitis Canada, discussed the pros and cons of industry-funded vs publically-funded patient support programs and the need for tools and education to support informed decision making by patients about biosimilars.
Session V: Biosimilar Awareness and Access
Don Husereau from the Institute of Health Economics in Alberta provided a pan-Canadian perspective on opportunities for biosimilars. He spoke to the cost effectiveness evaluation of drugs and the relationship between price and value. He outlined how value is shared between private industry and health systems, with health systems receiving their main share of value after a drug goes off-patent, depending on drug price and uptake. He concluded his presentation with a discussion of the challenges and opportunities that biosimilars represent for payers, patients, regulators, and drug manufacturers. For example, the perception that lower cost drugs are inferior and a lack of evidence to support interchangeability were described as challenges for payers. Opportunities included patient education and better price negotiations.
Session V ended with an open discussion that covered a wide range of topics including the robust body of evidence used by Health Canada to authorize a biosimilar, the challenge of optimizing the balance between the needs of individual patients and the need for care across many patients, and the need for information and education from trusted sources. Health Canada reiterated that the rigorous requirements for authorization based on the totality of evidence from quality, non-clinical and clinical studies serve to ensure that biosimilars authorized in Canada meet the same high standards for safety and efficacy as all other biologic drugs.
The workshop concluded with closing remarks from Liz Anne Gillham-Eisen, Acting Director of the Office of Policy and International Collaboration at BGTD, who spoke to the value of the diverse perspectives shared by different stakeholders at the workshop. She recapped common themes from throughout the day, highlighting that biosimilars are an evolving area where all stakeholders are learning. Take-home messages from the workshop include the promise of biosimilars for increasing Canadians' access to prescription drugs and gainsharing across healthcare systems, as well as the need for outreach and education initiatives on biosimilars and for opportunities for stakeholders to work collaboratively to help address common challenges.
For copies of Health Canada’s presentations from the workshop, please contact firstname.lastname@example.org.
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