IFA’s Position on Biosimilars
Drawing on the experiences of people living with vision loss and following extensive consultations and feedback, the International Federation on Ageing (IFA) – along with retinal specialists and allied patient organizations – agree on the following position related to biosimilars in ophthalmology: Safe, effective, and appropriate treatment of eye conditions determined by treating physicians in consultation with their patients.
Preserving vision in the management and treatment of retinal diseases is unlike other conditions where biosimilars may be applied and deserves special consideration. The invaluable experiences and guidance of stakeholders in therapeutic areas, such as rheumatology, oncology, gastroenterology, and others can help inform the development of an appropriate policy framework for ophthalmic biosimilars.
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Introducing the Eye See You (ESY) Program
Vision health is of utmost importance for healthy ageing, maintaining functional ability and ensuring good quality of life.
The Eye See You (ESY): Advocating for Options in Eye Health program collaborates across sectors and disciplines on matters that impact the vision health of all Canadians, in particular those with ageing-related vision complications. It provides a platform for knowledge exchange for a patient-centered approach to biosimilar policies. The ESY program calls on health policies that impact the treatment of eye conditions to be evidence-based and enable informed decision-making.
The ESY Program aims to mobilize evidence to influence and shape policy and practice around ageing-related vision complications to advance person-centred vision care. The Eye See You network aims to promote the vision health of all Canadians by empowering physicians to choose the optimal treatment for retinal diseases based on scientific evidence and conversation with patients. Additionally, the network aims to ensure that patients are better informed about the importance of regular eye screenings, the symptomatology of eye diseases, as well as the availability of effective treatment options. IFA aims to continue to reform and strengthen the Eye See You network and partnering relations and improve access and promotion of policy to ensure the patient and provider’s choice to treatment options are respected and protected.
What is a Biologic
Biologics are a class of medications produced from living organisms or their cells using biotechnology and are used to treat conditions, such as diabetes, rheumatoid arthritis, inflammatory bowel disease, and cancer. Biologic drugs are generally larger and more complex in composition than chemically produced pharmaceutical drugs.
What is a Biosimilar
Biosimilars are engineered to be highly similar but not identical to the already authorized originator/reference biologic product. There are no expected clinically meaningful differences in efficacy and safety between a biosimilar and the biologic drug. A biosimilar may enter the market – as a less costly and less time-consuming alternative – after the expiry of the originator biologic drug’s patents and data protection.
Currently there are significant knowledge gaps among older adults, patients and their caregivers, patient and advocacy organization as well as professional organizations regarding biosimilars in ophthalmology. The videos below are not intended to replace the knowledge gained in a thorough consultation with a health care professional but may provide an overview of biosimilars and are key resources in the national biosimilars discourse.
European Medicines Agency (EMA)
The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU)
Canadian Arthritis Patient Alliance (CAPA)
The Canadian Arthritis Patient Alliance (CAPA) is a volunteer based organization
The Gastrointestinal Society
The Gastrointestinal Society, a trusted registered Canadian charity
ESY Advocating for Options in Eye Health Program
Untreated retinal diseases such as age-related macular degeneration (AMD) and diabetic retinopathy (DR) can cause vision loss and blindness and is highly prevalent in Canada. For example (AMD) is one of the leading causes of vision loss in adults over 55 years of age, affecting about 2.5 million Canadians.
Sound evidence-based policy must underpin governmental decisions in funding new treatments, but equally important is the impact on management of the patient’s condition and the overall functional outcome. With the recent introduction of biosimilars in ophthalmology in Canada, now is the time to bring together key patient advocates across various vantage points to gain a deeper understanding of policy development and the patient voice.
ESY Advocating for Options in Eye Health Program is committed to:
Raising awareness about emerging vision-related policies
Facilitating timely access to educational resources about biosimilars
Connecting Canadians to experts and thought leaders in vision health
Creating opportunities for Canadians to engage in discourse surrounding biosimilars in ophthalmology
Rapid population ageing, coupled with increased prevalence of chronic diseases such as diabetes, both disproportionately affect the vision of older people with 77% of vision loss occurring in adults 50 years of age and older.
Unlike other chronic diseases where biosimilars presents a treatment alternative, vision loss due to retinal diseases, including age-related macular degeneration (AMD) and diabetic retinopathy (DR), is often irreversible as small variations can lead to complications due to the nature of intravitreal administration.
An emerging trend in Canada is the use of biosimilars as a cost-saving alternative treatment to biologics in rheumatology, gastroenterology, oncology, endocrinology, dermatology and other areas of medicine. As biosimilars are now becoming available for ophthalmic conditions in Canada, there remain concerns on the limited guidelines and education efforts. Lack of awareness on biosimilars amongst both patient and physician communities, due to non-targeted educational materials poses a barrier to acceptance.
Recent biosimilars policies across Canada require non-medical forced switching from current, physician-prescribed biologics medicine to government-preferred biosimilar. This is concerning in the field of ophthalmology because currently there are no studies demonstrating the impact of non-medical forced switching to biosimilars and no clinical data available on the appropriate use of biosimilars when it comes to vision loss treatment. A mandatory, non-medical forced switch, takes away patient choice, preventing them from being active in the decision-making process of their treatment plans.