How Canada became the preferred launchpad for ophthalmic biosimilars in 2025

What factors make Canada a top choice for biosimilar makers launching ophthalmology products?

In a strategic move that’s reshaping global biosimilar launch sequencing, Biocon Biologics Limited selected Canada as the first market to launch Yesafili™, a biosimilar version of aflibercept (Eylea®), following Health Canada’s Notice of Compliance on June 26, 2025. The launch, scheduled for July 4, 2025, marks the first time any biosimilar to Eylea has received market authorization in the country. And it may be just the beginning.

This milestone highlights a broader trend: global biosimilar developers are increasingly choosing Canada as the ideal springboard for ophthalmology-focused biologics. Whether the goal is to validate regulatory science, engage with single-payer systems, or gather early real-world evidence, Canada’s healthcare and regulatory environment now offers an optimized launch pathway—especially for retina care biologics like aflibercept.

How has Health Canada positioned itself as a regulatory leader in biosimilar approvals?

Health Canada has steadily evolved its biosimilar review framework over the past decade, aligning scientific rigor with an efficient, globally harmonized approach. The process includes comprehensive analytical, nonclinical, and clinical reviews, but without the excessive procedural hurdles seen in jurisdictions like the United States.

For ophthalmology, where switching between reference and biosimilar products is more medically sensitive, Health Canada’s detailed guidance on therapeutic equivalence and product monographs offers clarity to both prescribers and developers. Importantly, the agency does not require a separate “interchangeability” designation—lowering a key regulatory barrier.

Biocon Biologics’ Yesafili approval followed a positive assessment of comparative data, including findings from the global Phase 3 INSIGHT study in diabetic macular edema patients. Analysts believe that Health Canada’s early greenlight not only validated Biocon’s dossier strength but also underscored Canada’s readiness to lead biosimilar ophthalmology adoption.

What payer and procurement mechanisms support early biosimilar uptake in Canada?

Canada’s provincial drug reimbursement systems, coupled with federal frameworks like the pan-Canadian Pharmaceutical Alliance (pCPA), favor cost-effective alternatives. In recent years, provinces such as British Columbia, Alberta, and Ontario have implemented biosimilar switching policies across immunology and endocrinology, setting the stage for ophthalmology to follow.

Hospitals and public health networks are incentivized to adopt biosimilars through formulary inclusion, group purchasing contracts, and volume-linked rebates. These mechanisms, backed by public payer mandates, significantly accelerate time-to-market adoption—something that global biosimilar firms recognize as commercially advantageous.

Institutional investors point out that Canada’s centralized procurement model may allow biosimilar aflibercept developers to rapidly gain 20–30% market share within 18 months of launch if pricing and access conditions are favorable. For Biocon Biologics, this could turn Yesafili’s launch into a blueprint for ophthalmic biosimilar strategies elsewhere.

Why are developers prioritizing Canada over the U.S. or Europe for first launches?

Compared to the U.S. Food and Drug Administration (FDA), which still maintains separate requirements for biosimilarity and interchangeability designations, Health Canada provides a unified regulatory path that avoids additional market entry delays. The FDA has not yet approved any aflibercept biosimilar as of July 2025, despite multiple development programs being in late-stage review.

In Europe, while the European Medicines Agency (EMA) has a longer history of biosimilar approvals, the decentralized health systems across member states introduce variability in pricing, tenders, and time to commercial uptake. Canada, by contrast, offers a harmonized federal–provincial ecosystem and a population base that supports early commercial viability without needing blockbuster volumes.

According to institutional feedback, developers also see Canada as a strategically neutral market to test clinical messaging, safety monitoring protocols, and stakeholder education before scaling to more complex markets like the U.S.

How does Canada’s approach to pharmacovigilance and post-market monitoring support biosimilar trust?

Health Canada’s approach to pharmacovigilance for biosimilars is anchored in proactive signal detection and close manufacturer collaboration. Biocon Biologics, for instance, has set up a dedicated Canadian toll-free line for reporting suspected adverse events related to Yesafili, aligning with federal expectations.

The Canadian product monograph for Yesafili contains extensive detail on known risks such as endophthalmitis, intraocular inflammation, retinal detachment, and increased intraocular pressure. This transparency builds trust among ophthalmologists—an essential requirement in a field where intravitreal biologics are administered directly into the eye.

Experts also note that real-world data from Canadian hospitals can later be used to support health technology assessments (HTAs) and reimbursement filings in countries like Australia, New Zealand, and select EU nations—extending Canada’s influence beyond its domestic market.

What is the potential market size for biosimilar aflibercept in Canada by 2026?

While Canada’s population is under 40 million, the retinal disease burden is growing rapidly due to aging demographics and increasing diabetes prevalence. Anti-VEGF therapies like aflibercept represent a major cost component for provincial health plans, making biosimilar alternatives a policy imperative.

Industry analysts project that the biosimilar market for aflibercept in Canada could exceed CAD 100 million annually by 2026, assuming formulary access and physician uptake. With Yesafili launching first, Biocon Biologics is in a position to capture meaningful share—particularly if it wins early hospital and public tender contracts.

Market intelligence also suggests that rival products from Samsung Bioepis, Formycon, and potentially Amgen are tracking Canada for secondary filings following Biocon’s lead. However, pricing flexibility and supply reliability will ultimately determine commercial outcomes.

What does Canada’s biosimilar trajectory mean for global ophthalmology developers in the post-Eylea era?

The Canadian biosimilar market has evolved into a credible proving ground for global developers, particularly in therapeutic segments where affordability, real-world data, and physician trust are paramount. Having already matured in oncology, endocrinology, and immunology, Canada is now extending its influence into ophthalmology biosimilars—a space historically dominated by high-cost innovator brands with limited generic pressure.

With the approval of Yesafili by Health Canada, Canada becomes the first regulated market worldwide to authorize a biosimilar version of aflibercept (Eylea), a VEGF inhibitor widely used to treat retinal disorders such as diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). This milestone sets a regulatory precedent that developers from India, South Korea, and the European Union are expected to monitor closely as they plan their commercial strategies for the next wave of ophthalmic biosimilars.

For biosimilar developers planning launches between 2026 and 2028, Canada offers multiple advantages beyond early revenue. It provides a structured and transparent path for validating real-world switching protocols, engaging with hospital networks, and building a safety and immunogenicity profile through post-market surveillance—all within a payer system that actively rewards cost-effective alternatives. These data points, when captured in Canada’s integrated healthcare setting, carry persuasive weight in secondary markets such as Australia, New Zealand, and selected EU nations where health technology assessments (HTAs) require robust outcomes-based justification.

Institutional sentiment increasingly views Canada as the ideal pilot market for ophthalmic biosimilar launches, offering lower legal and regulatory risk compared to the United States while still reflecting Western prescribing practices. Canadian physician associations and retinal specialist groups have begun integrating biosimilar education into clinical guidelines, supported by Health Canada’s regulatory clarity on therapeutic equivalence and switching safety. This environment gives biosimilar developers a rare opportunity to influence adoption curves while shaping payer perceptions early in the product lifecycle.

Moreover, market access teams across biosimilar firms are recalibrating their sequencing strategies. With the U.S. Food and Drug Administration’s (FDA) biosimilar interchangeability designation still evolving—especially for sensitive delivery routes like intravitreal injection—Canada’s more unified approach allows for a smoother launch pathway. As a result, developers may increasingly adopt a “Canada first, U.S. later” commercialization strategy, particularly for complex biologics such as VEGF inhibitors, anti-TNF agents with ocular indications, and extended-release ophthalmology formulations.

From a commercial perspective, a successful rollout of Yesafili could accelerate biosimilar tendering activity within provincial procurement bodies and influence global biosimilar price benchmarks. Canadian real-world usage data may also help biosimilar developers defend the value proposition of aflibercept alternatives in markets where switching hesitancy or formulary inertia remains an obstacle.

Ultimately, Canada’s trajectory in biosimilar ophthalmology may determine not only the fate of aflibercept competitors but also shape global norms for how high-cost retinal therapies are made more accessible. In this new era of cost-sensitive biologics, regulatory pragmatism and data-driven trust—both strengths of Canada’s healthcare system—are emerging as critical drivers of success.