Welcome to the Knowledge Resource Hub
The global population is rapidly changing, resulting in a shift in demographic distributions toward older ages, known as population ageing. The population aged 65 years and over is growing faster than all other age groups, with the number of people aged 60 years and over expected to increase from 962 million in 2017 to 1.4 billion by 2030.1 Parallel to population ageing is the increasing prevalence of non-communicable diseases (NCDs), including diabetes, heart and lung diseases.
In the context of vision health, population ageing and NCDs are important to consider as they are related to vision complications. As the population ages, the number of people with eye conditions, such as age-related macular degeneration (AMD) is expected to rise. Likewise, NCDs (particularly diabetes) are linked to vision loss, often irreversible because retinal diseases – including diabetic retinopathy (DR) – are sight threatening and the retina has limited ability to recover. In Canada over 90 percent of ophthalmic procedures are performed on Canadians aged 65 years or over, with AMD and DR being two of the top five eye conditions that contribute to the majority of vision loss nationally.2 Globally, older people disproportionately experience vision impairment with 77% of vision loss occurring in adults 50 years of age and older.
Vision health is of utmost importance for healthy ageing, maintaining functional ability and ensuring good quality of life. As the global population ages, and with increasing prevalence of chronic diseases, the International Federation on Ageing (IFA) recognizes the need to ensure appropriate and timely vision care for all. Through the Eye See You (ESY) program, the IFA aims to advance person-centred vision care by mobilizing evidence to influence policy and practice around ageing-related vision complications.
Biologics are a class of medications produced by living cells using recombinant DNA technology and are used to treat conditions in rheumatology, oncology, gastroenterology, ophthalmology, and other areas of medicine. Originator biologic drugs are patented, meaning their owners have been granted a legal right to exclude others from making, using or selling the product for a set period of time in exchange for disclosing information about the invention/product. However, as patents expire on originator biologics, other manufacturers can develop and sell products designed using the information that was disclosed about the originator biologics. In this light, biosimilars engineered to be highly similar to the reference products (originator biologics) are entering markets. They are a less costly and less time-consuming alternative to manufacture since they do not have to go through the same lengthy process of being tested as do the originator biologics. Instead, biosimilars are tested through different, although rigorous studies, but which take less time prior to their authorization for sale.
The use of biosimilars dates to 2006, when the first human growth hormone biosimilar was approved by both the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Since then, biosimilars have been used worldwide, with Europe having the largest biosimilar market in the world. Biosimilars were introduced to Canada in 2009 and the first ophthalmic biosimilar was announced in late 2022. They are approved by Health Canada for their use to treat medical conditions, such as rheumatoid arthritis, psoriasis, inflammatory bowel disease, certain cancers and diabetes. Health Canada also monitors biosimilars for their safety and effectiveness following their authorization for sale.
The vision health landscape in Canada is quickly evolving, with ophthalmic biosimilars approved for the treatment of retinal conditions. Despite various federal and provincial consultations to inform biosimilars policies, significantly less attention has been given to the field of ophthalmology.
Europe has significant and successful experience in the development and uptake of biosimilars, which is widely credited3 because policies preserve physician choice and forced switching to biosimilars is rejected.4 Contrary to Europe, provinces in Canada have implemented forced switching policies, requiring thousands of Canadians to be switched from their originator, physician-prescribed biologic medicines to the government-preferred biosimilars. Recently, the first ophthalmic biosimilar has been introduced into the Canadian marketplace placing the forced switching policy and the vision health of Canadians front and center.
As such, there is an increasing concern from patient and advocacy organizations regarding the basis for biosimilar policies and the impact on current and future patients. Medical societies, including the Canadian Ophthalmology Society, the Canadian Retina Society, the American Academy of Ophthalmology, alongside patient and advocacy organizations such as the IFA have issued statements opposing forced switching policies. The situation necessitates the voices of global experts, namely clinicians, patients, caregivers and advocates to help inform the development of ophthalmic biosimilar policies together with the urgent creation of evidence-based educational materials, guidelines and protocols.
There is concern about biosimilar policies not reflective of the importance of patient and physician choice, and rather mandate the use of biosimilars that constrain physicians from treating their patients with the most appropriate medicine based on their expertise. While biosimilars provide greater treatment options for patients, data on the impact of mandatory non-medical switching of ophthalmic medications is not available and the rationale for it is not consistent with international best practices. For example, as Europe has demonstrated that forced switching is not required for successful uptake of biosimilars. insufficient data to support switching from originator biologics to biosimilars remains a point of contention with policies that have already been enacted across Canadian provinces. In a survey of 41 Canadian ophthalmologists conducted by the Alliance for Safe Biologic Medicines (ASBM) in collaboration with the IFA, revealed that 81% of respondents were not comfortable with a government switch of a patient’s medicine for non-medical reasons, such as cost. Furthermore, 90% of physicians indicate that having sole authority, with their patient, to decide which biologic medicine is most suitable is very important or critical, validating the significance of choice.
To address the growing concern surrounding mandatory non-medical switching policies for biosimilars, the IFA raises awareness on the importance of eye health, prevention of vision loss, treatment options available and how patients can ensure their health rights are not restricted. Patient and physician choice needs to be respected and, while a focus on health system efficiencies is important, it should not be employed at the cost of a Canadian’s eyesight.
The ESY program calls on health policies that impact the treatment of eye conditions to be evidence-based and enable informed decision making. Clinical dialogue in conjunction with comprehensive patient education are foundational elements of a vision health plan and policy framework for the use of biosimilars in ophthalmology to achieve the goal of sustainable access and affordability. Patient choice in consultation with the treating physician, alongside the principles of safe, effective and appropriate management and treatment must be the norm, not the exception.
As emerging biosimilars in ophthalmology come to the forefront, there is an urgent need to help improve the awareness and understanding of such products and policies among Canadian patients and their families through clear, concise and evidence-based information. With increasing literature available on the safety, efficacy and outcomes associated with biosimilars, the ESY program is committed to ensure the information is accessible and reaches those most at need. The IFA, through the ESY program, is positioned to help build capacity and capability across sectors and disciplines to address knowledge gaps and amplify collective voices of older Canadians with blinding eye diseases and their health professionals in calling for access to appropriate, safe and effective vision treatments.
The “Biosimilars in Ophthalmology Knowledge Resource Hub” provides access to information, recent news and evidence-based tools about vision health and biosimilars to support patients, caregivers and providers. The Hub is adaptable and dynamic, with resources continually curated and updated according to emerging needs, best evidence and drawing on the collective expertise and engagement of our partners, such as Canadian Council of the Blind (CCB) and Alliance for Safe Biologic Medicines (ASBM) to mobilize knowledge and vitalize the hub through ongoing curation.
Resources
As the development and implementation of biosimilars and their policies has implications on the management and access to treatments for patients, it is important to mobilize the patient advocacy community. Patient voices as experts with lived experience is crucial to help inform the development of ophthalmic biosimilar policies and evidence-based resources.
The International Federation on Ageing (IFA) and the Eye See You (ESY) program partnered with the South Riverdale Community Health Centre (SRCHC) Teleophthalmology Clinic to gather patient stories about their experiences with the Teleophthalmology program (including the education and support they received) and the broader issue of vision health in Toronto, such as the importance of eye screening and early detection.
The IFA interviewed a few patients of the Teleophthalmology Clinic as part of the ESY May 2017 vision health month campaign to understand barriers patients face in accessing vision health care services. Questions asked include why eye health is important to them, their experience receiving eye health treatment in general, and the services provided by the Teleophthalmology program specifically. The SRCHC Diabetes Eye Screening Program – Teleophthalmology provides free annual diabetes eye screening to adults over 18 years of age that have diabetes – either gestational, type 1 or type 2. The purpose of the Teleophthalmology program is to reduce the possibility of diabetes-related damage to the eyes (retinopathy) which could result in vision loss.
Christine’s Story
Tom’s Story
Don’s Story
The IFA would like to thank the SRCHC and the patients for their time and input into the video recording process.
Whether you suffer from vision loss; have a family member or loved one that has vision loss; are at risk of vision loss; and/or have knowledge that you would like to share about vision loss, the Eye See You Campaign is interested in hearing your story.
To be considered, simply complete this form and the IFA will be in touch soon.
Definitions
A gradually developing form of age-related macular degeneration (AMD) disease and known to be one of the major vision disabling diseases, mostly targeting older people. For more information, click here: https://eyeseeyou.care/en/geographic-atrophy/
Biologic is biopharmaceutical medicine used to treat chronic diseases. It is a pharmaceutical drug that is generally made from biological sources (i.e., living organisms), such as animals and microorganisms (i.e., yeast and bacteria), hence the name biopharmaceutical. Biologics are usually larger and more complex in composition than chemically produced medicines. Ranibizumab and Aflibercept are examples of ophthalmic biologics.
A biosimilar is a new version of the biologic medicine. It is a biopharmaceutical drug made to be highly similar to an approved originator/reference biologic drug with no meaningful differences in safety, purity and efficacy.
A change from routine use of one specific product to the routine use of another specific product. Biosimilars are authorized by Health Canada for the indications (applicable uses to treat specific diseases or conditions) listed in the Product Monograph. Biosimilars can be authorized for the same indications/uses as their reference biologics with no differences expected in safety and efficacy following change from the routine use of the biologic to the biosimilar.
When a drug is expected to have the same clinical result as the reference drug, they are considered interchangeable. Note: The authority to declare two drugs interchangeable rests with each Canadian province and territory according to its own rules and regulations. Drugs deemed interchangeable may be noted on the provincial Drug Benefit List.
Dispensing one product in place of another, if they are considered interchangeable. The pharmacist can dispense an equivalent, interchangeable drug without the involvement of the physician who wrote the prescription.
More Information
1. World Health Organization (2019). World Report on Vision. Geneva, Switzerland. License: CC BY-NC-SA 3.0 IGO
2. Gagnon-Arpin I, D’Angelo MS, Moroz N, Ye Z. (2020). Ophthalmology in Canada: Why Vision Loss Should Not Be Overlooked. Conference Board of Canada. Retrieved from https://www.conferenceboard.ca/product/ophthalmology-in-canada-why-vision-loss-should-not-be-overlooked/
3. Reilly MS & Schneider PJ. Policy recommendations for a sustainable biosimilars market: lessons from Europe. 2020: 9(2): 76-83. Retrieved from https://gabi-journal.net/policy-recommendations-for-a-sustainable-biosimilars-market-lessons-from-europe.html
4. Reilly MS & Spiegel A. 1633PD. Biosimilar Substitution: European Prescriber Perspectives. Poster presentation at: Annual Congress of the European Society of Medical Oncology; Barcelona, Spain. September 27 – October 1, 2019.
Partners Resources
The Canadian Council of the Blind (CCB) is a non-profit organization bringing together Canadians who are blind, deaf-blind, or living with vision loss through local community CCB chapters.
Cost of vision loss and blindness in Canada report
CanAge is Canada’s national seniors’ advocacy organization, working to improve the lives of older adults through advocacy, policy, and community engagement.
The use of biosimilar treatments in ophthalmology
The Alliance for Safe Biologic Medicines is an organization composed of diverse healthcare groups and individuals—from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.
Canadian prescribers’ attitudes and perceptions about ophthalmic biosimilars
The Canadian Ophthalmological Society (COS) is the national, recognized authority on eye and vision care in Canada.
Canadian Ophthalmological Society (COS) position statement on biosimilars
Canadian Ophthalmological Society (COS) joint position statement on biosimilar drugs
The Canadian Retina Society (CRS) represents the Ophthalmologists in Canada whose primary area of patient care is surgical and/or medical vitreoretinal disease. The CRS empowers its members to perform at the leading edge of patient care by providing opportunities for research, collaboration, and professional development.
