Can Indian biosimilar makers dominate ophthalmology markets after Eylea patent expiries?

What does Biocon Biologics’ Health Canada approval for Yesafili signal for Indian firms entering retinal biosimilars?

Biocon Biologics Limited’s recent Health Canada approval for Yesafili, a biosimilar of aflibercept (Eylea), has opened the first meaningful pathway for Indian biopharmaceutical companies into the global ophthalmology biosimilars segment. With this milestone, Biocon Biologics became the first player worldwide to secure market clearance for an Eylea biosimilar in Canada, just weeks ahead of expected launches in additional regulated markets. The move is not only significant for Biocon but also marks a signal event for other Indian biosimilar makers preparing to enter one of the most lucrative biologics niches globally—retinal anti-VEGF therapies.

The Eylea franchise, jointly marketed by Regeneron and Bayer, remains one of the highest-revenue biologic products in the world, with global sales exceeding USD 9 billion in 2023. Given that several patents covering aflibercept formulations and dosing regimens have already expired or are approaching expiration across major jurisdictions, Indian biosimilar players are rapidly positioning themselves to tap into these emerging gaps.

Which Indian pharmaceutical firms are advancing biosimilars in ophthalmology and aflibercept specifically?

While Biocon Biologics has taken the lead with Yesafili’s regulatory approval in Canada, other Indian pharmaceutical companies have also disclosed active pipelines targeting ophthalmology—either directly or through platform expansions. Zydus Lifesciences has signaled interest in anti-VEGF biosimilars, though it has not publicly disclosed any aflibercept-specific asset. Lupin Limited, on the other hand, has made ophthalmology a priority area within its broader biosimilars and complex generics strategy, recently announcing development progress in retina-focused injectable therapies.

As of mid-2025, Biocon Biologics remains the only Indian-origin company with a validated clinical dossier in a regulated market for aflibercept. Its Phase 3 INSIGHT study in diabetic macular edema patients, which underpinned the Health Canada approval, may serve as a template for future filings in Australia, Europe, and eventually the United States—where interchangeability standards and payer dynamics are more complex.

Analysts note that Indian biosimilar manufacturers may be following different routes to market. While Biocon has focused on direct regulatory filings backed by global clinical trials, others are exploring co-development models with EU-based CDMOs or licensing deals with emerging market distributors.

How are global patent expiries and legal settlements reshaping biosimilar opportunities in ophthalmology?

In the United States, Eylea faced its first biosimilar challenge from Samsung Bioepis and Mylan (now part of Viatris), which led to a patent settlement allowing for a potential launch of SB15 (biosimilar aflibercept) in 2025. This timeline creates a narrow but high-stakes window for other players, including Biocon Biologics, to file their dossiers and pursue FDA approval either under 351(k) or potentially seek interchangeability status.

Europe has seen several secondary patents lapse or be invalidated, making the market increasingly accessible for biosimilar aflibercept filings. Indian companies with strong regulatory experience in the EMA pathway—like Cipla, Biocon, and Dr. Reddy’s Laboratories—are likely to target ophthalmology as a natural next step, given the high cost burden of anti-VEGF therapies on public health systems.

Industry observers expect biosimilar competition to intensify from 2026 onward, with at least 6–8 biosimilar aflibercept products likely to be approved across the U.S., EU, Canada, and Australia. Indian drugmakers with early regulatory wins—especially in Canada and emerging Asia-Pacific markets—could build a valuable first-mover advantage in formulary access.

What challenges do Indian biosimilar makers face in the ophthalmology space compared to other therapy areas?

While Indian companies have already established themselves as global leaders in insulin, oncology, and rheumatology biosimilars, ophthalmology presents distinct hurdles. The first is the complexity of delivering high-concentration biologics safely through intravitreal injection. This requires not only precision manufacturing but also specialized device delivery systems such as prefilled syringes, which must meet stringent particulate and sterility standards.

Second, biosimilars in ophthalmology face cautious adoption by retinal specialists, especially in North America and Europe. Unlike biosimilars in immunology where switching protocols are well established, ophthalmology remains conservative due to patient risk profiles and the limited interchangeability guidance from regulators like the U.S. FDA.

Third, market penetration for ophthalmic biosimilars hinges heavily on payor policies, hospital procurement systems, and real-world evidence collection. Indian firms will need to build trust through data and long-term pharmacovigilance in addition to competitive pricing—an area where Biocon Biologics has a head start, but where rivals must still build capabilities.

How might pricing and market access strategies determine long-term success for Indian biosimilars?

Canadian reimbursement structures and provincial formularies, which favor cost-effective alternatives, provide an ideal testing ground for pricing strategies. Biocon Biologics’ Yesafili launch will serve as a real-time case study for other Indian biosimilar developers evaluating market access pathways for retina care biologics.

Pricing in ophthalmology, especially for high-cost biologics like Eylea and Lucentis, remains a decisive factor. While Regeneron and Bayer have introduced higher-dose, longer-acting versions of aflibercept, payors remain under pressure to adopt biosimilars that offer meaningful cost reductions. Indian companies have proven adept at price-based disruption in insulins and monoclonal antibodies, and will likely use similar playbooks for retina therapies—supported by in-market evidence from real-world deployments.

Formulary access, physician buy-in, and rapid volume ramp-up through hospital networks will be the three pillars of a successful biosimilar aflibercept strategy. With price wars expected once multiple biosimilars reach the market post-2026, Indian firms will need to balance margin preservation with volume-led growth.

What does the future look like for India’s position in the global ophthalmology biosimilars market?

India’s pharmaceutical sector, particularly its biosimilar segment, is entering a maturity phase in which product development is expanding beyond me-too insulins and TNF inhibitors. Ophthalmology offers an attractive, underpenetrated frontier with high unmet needs, especially in aging populations.

Biocon Biologics’ early bet on aflibercept, and its upcoming Yesafili launch in Canada, gives it a head start that may be difficult for domestic peers to match in the short term. However, as more Indian players file for global approvals, the 2026–2028 period could become a turning point where India emerges as a dominant force in retinal biosimilars.

With multiple biosimilar VEGF inhibitors already in development globally and a growing focus on long-acting formulations, Indian firms that can combine formulation innovation, cost efficiency, and regulatory depth may very well define the next era of ophthalmology biologics access.