A quiet revolution in ophthalmology is underway as biosimilars enter the retina space, promising to redefine practice economics
A quiet shift is gaining momentum in the field of ophthalmology. Biosimilars—near-identical copies of approved biologic drugs—are edging into the retina space, offering a fresh set of tools to tackle some of the most common and costly vision-threatening diseases.
Like a chef considering different brands of knives in their kitchen, retina specialists now face expanding choices in their treatment arsenal, each with potential implications for patient care, practice economics and the broader healthcare system.
“Biosimilars are an inevitable evolution of the lifecycle of a therapeutic,” explained Dr. Paul Hahn, a retina specialist at NJRetina (USA). “I don’t think they are likely to demonstrate any meaningful efficacy benefits compared to the reference therapy, but their potential cost savings may be meaningful drivers to promote utilization.”
READ MORE: The Rise of Anti-VEGF Biosimilars and Biobetters
A changing landscape
The biosimilar story in retina care began in 2021 when the FDA greenlit Byooviz (ranibizumab-nuna; Samsung Bioepis; Incheon, South Korea). Since then, a few more ranibizumab biosimilars have entered the market, including Cimerli (ranibizumab-eqrn; Sandoz; Basel, Switzerland), which received an interchangeability designation from the FDA.
READ MORE: Byooviz: Ophthalmology’s First Biosimilar
Now, aflibercept biosimilars are stepping into the spotlight. Most notably, Biocon Biologics (Bengaluru, India) recently reached a settlement with Regeneron (New York, USA), clearing the path to launch Yesafili (aflibercept-jbvf)—an interchangeable biosimilar to Eylea—in the U.S. by late 2026, or earlier under specific terms.
“This settlement clears the path for Biocon Biologics to be among the first to bring a reliable, high-quality aflibercept biosimilar to patients and healthcare providers in the United States,” said Biocon’s CEO, Shreehas Tambe, in a news release.
It’s a bold step in a big territory. Eylea raked in roughly $9.4 billion in 2023, and the market is expected to grow to $12.73 billion in 2028—making it a tempting target for biosimilar competition.1
READ MORE: Eylea 8 mg Approved in EU for 6-Month Dosing in nAMD and DME
Understanding biosimilars
Unlike generic drugs—carbon copies of small-molecule medications—biosimilars are a different beast. They’re large, complex proteins brewed from living cells, which makes it impossible to create an exact replica of the original biologic. But although they can’t be identical, they’re very similar, close enough in structure, purity and potency to match the reference drug in performance.
“By definition, molecular and protein characteristics of a biosimilar must be similar to those of the reference product,” explained Bressler et al. in a review published in Survey of Ophthalmology. “Biologics have per se a certain inherent microheterogeneity.” Translation: Tiny differences are baked into the process. These arise from natural variations in the living cells used to make the drug, as well as minor shifts in manufacturing.2
This inherent variability means that even different batches of the same reference product aren’t absolutely identical to each other. As Bressler et al. noted, “batches of the reference ranibizumab product (Lucentis) from 2018 were likely not absolutely identical to batches of this product in 2022.”2
To get FDA approval, biosimilars must undergo rigorous testing to prove they’re clinically equivalent, though the development process is faster and less costly than for original biologics.2
“It’s frankly cheaper to develop a biosimilar because you don’t have an original pathway to go through,” explained Dr. Suber Huang, CEO of the Retina Center of Ohio (USA). “For instance, with Avastin, you would have to go through an entire new process to create a biosimilar, because Avastin (bevacizumab) was not a reference drug for the eye.”
READ MORE: Intravitreal Bevacizumab Receives EU Approval for Wet AMD Treatment
The cost equation
One of the biggest motivators driving biosimilar development is cold, hard cash savings. The first ranibizumab biosimilar hit the market with a 40% price cut compared to its reference product, and the difference in average sale price was approximately 31.3%. This represents significant potential savings, considering that patients with conditions like neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) may receive an average of nine injections in the first year of treatment alone.2
A Canadian estimate projected that switching to ranibizumab biosimilars could save between 70 and 201 million CAD in 2023. With a similar market dynamic, the U.S. could be in line for major savings too, especially as more biosimilars enter the fray and start competing on cost.2
Of course, saving money is only a possibility if biosimilars are used. That’s where uptake comes in. “When you have a cheaper option…the patients, insurers, society and healthcare system in general will tend to favor those if there’s equal efficacy and equal safety,” said Dr. Huang.
Clinical experience and adoption challenges
Despite their potential to cut costs and expand access, biosimilars in ophthalmology have had something of a slow start. In 2023, they made up just 3% of usage, bumping up only modestly to around 10% in 2024.3
So, what’s behind the hesitation? According to Dr. Hahn, it’s not that retina specialists doubt biosimilars work. “I think when biosimilars first became part of a consideration in the retinal armamentarium, there was a lot of hesitation around these,” he explained. “I think that exists because biosimilars are now here, not because of efficacy; they don’t work better than our reference products. But it’s a cost consideration, and many of us as doctors are used to not thinking about what costs less for the patient. Rather we’re used to thinking about what works best for our patient. It’s a different mindset.”3
That mindset shift is slowly happening, and among those who’ve already made the leap, the results have been promising. “We have incorporated ranibizumab biosimilars in our practice, both with new and existing treatment patients. The integration was generally smooth,” said Dr. Hahn. “Once our physicians felt comfortable with the safety and efficacy profile, patients generally did not have concerns following the recommendations of their doctor.”
READ MORE: Anti-VEGF Biosimilars for nAMD
The step therapy conundrum
When it comes to biosimilars, retina specialists aren’t losing sleep over the drugs themselves. However, they are raising eyebrows at how insurers might use them to enforce restrictive step therapy protocols.
“One of the biggest problems I see is the mandate for step therapy,” said Dr. Huang. “When insurers mandate what drugs you must try in what order, I think that’s an anathema to the practice of medicine.”
Dr. Hahn echoed the same concern. “With multiple biosimilars now on the market, along with an off-label but even less costly option also available, retina specialists are now burdened with multiple ‘steps,’ with failure at each one required in order to advance to a different therapy,” he explained.
And these steps aren’t just theoretical. According to the Kaiser Family Foundation, 98% of Medicare Advantage plans now use step therapy for Part B drugs, impacting more than 40% of Medicare beneficiaries. In practice, this often means starting treatment with compounded bevacizumab, and only moving to FDA-approved brand-name drugs after that option “fails.”4
The ophthalmology community is not taking this lying down. As Dr. Hahn noted, organizations like the American Society of Retina Specialists (ASRS) “vigorously defend physician judgment and choice in therapy selection.” The American Academy of Ophthalmology (AAO), for its part, has also pushed back, stating that “the choice of drug treatment should be a shared decision between the patient and their physician after a thorough discussion of the risks and benefits of each treatment and not determined by insurance companies.”5
Patient communication and acceptance
When it comes to talking biosimilars with patients, retina specialists have found that a clear, no-fuss explanation tends to do the trick.
“Patients generally understand the role of and are comfortable with the use of generic medicines. I explain that biosimilars are the equivalent of a generic for these injectable therapies, and patients usually do not have concerns,” said Dr. Hahn. “For those who do have concerns, I explain that we have multiple options, and if we do not obtain expected outcomes, we can always switch to a different therapy.”
While patient education is still important, especially as biosimilars gain traction, there’s a bit of a knowledge gap to bridge. One industry report found that 50% reported knowing “a little” about biologics and biosimilars. That said, in ophthalmology, where injections are administered by the physician, patient buy-in may matter less than physician confidence in the product. Still, a little clarity never hurts.6
READ MORE: How Close Are We to Finally Solving the Retinal Treatment Burden?
The future of biosimilars in retinal care
As more biosimilars make their way into the treatment toolkit, and as clinicians grow more comfortable using them, the landscape of retinal disease management is bound to shift. But just how big of a shift? Well, that depends on who you ask.
Dr. Hahn doesn’t see biosimilars as game-changers so much as helpful additions. “In contrast to upcoming innovative approaches to the treatment of retinal diseases currently in development, I do not think biosimilars will fundamentally shift the way we approach retinal disease,” he said. “The availability of more treatment options in the arsenal is generally valuable, particularly as the cost of treatment remains increasingly important at a societal and individual patient level.”
Dr. Huang, meanwhile, posed a thought-provoking question about priorities in drug development. “All the time and money spent in biomedical research…those resources are then used for something that is, in fact, not any better than something we already have,” he noted. “If it never improves, then we lose a very valuable part of what we do, which is to try to come up with something better.”
That said, Dr. Huang was quick to acknowledge the other side of the coin. “If a biosimilar costs less, more people can afford it. And if more people can access it—and it works just as well—then you’ve improved care in a different, but still meaningful, way,” he added.
A new set of tools in the kitchen
As we find our way in the new era of biosimilars in ophthalmology, perhaps Dr. Huang puts it best with a culinary metaphor: “If a knife is made by two different manufacturers, it’s still a knife, and you prepare dinner just the same.”
In other words, biosimilars don’t reinvent the recipe for treating retinal disease. But they do give retina specialists a wider array of tools to work with. Tools that, while functionally similar, come with different price tags. Just as you don’t need a Masamoto blade to chop an onion, you don’t always need a brand-name biologic to treat a patient effectively.
The catch? Making sure these extra options empower physicians rather than tie their hands. “As a society, we must ensure that these additional modalities provide increased options for physician choice rather than restricting options,” Dr. Hahn warned.
With smart education, thoughtful rollout, and a watchful eye on both safety and outcomes, biosimilars could play a meaningful role in expanding access to care while easing the financial strain of retinal disease treatment. In that way, they’re not just another set of knives. They’re a chance to cook up better outcomes for more patients.
Preparing for the Biosimilar Era
For retina specialists looking to integrate biosimilars into their practice, a little preparation can go a long way toward a smooth transition. Here are a few key things to keep in mind:
- Do your homework: Brush up on clinical trial data and real-world evidence to get a solid grasp of each biosimilar’s safety and efficacy.
- Know the fine print: Get familiar with regulatory terms like “interchangeability,” and more importantly, what those labels do (and don’t) mean for your day-to-day clinical decisions.
- Have your elevator pitch ready: A clear, no-nonsense way to explain biosimilars to patients will help put their minds at ease.
- Watch the insurance shuffle: As biosimilars become more common, be ready for shifting coverage policies and the possible maze of step therapy.
- Track your results: Monitor patient outcomes to build your own comfort and confidence in these agents.
Ultimately, trust is the secret sauce. “Patients trust their doctor,” reminded Dr. Hahn. “If you are comfortable with the treatment plan that you are offering to the patient, the patient will often be comfortable as well.”
References
- Eylea (Aflibercept) Market Research Report 2025: Strategic Partnerships and Biosimilars Enhance Accessibility, Diabetes-Related Retinal Issues and Myopia Surge Boost – Long-term Forecasts to 2033. Research and Markets. February 12, 2025. Available at: https://www.globenewswire.com/news-release/2025/02/12/3024804/28124/en/Eylea-Aflibercept-Market-Research-Report-2025-Strategic-Partnerships-and-Biosimilars-Enhance-Accessibility-Diabetes-Related-Retinal-Issues-and-Myopia-Surge-Boost-Long-term-Forecast.html. Accessed on June 2, 2025.
- Bressler NM, Kaiser PK, Do DV, et al. Biosimilars of anti-vascular endothelial growth factor for ophthalmic diseases: A review. Surv Ophthalmol. 2024;69(4):521-538.
- Jeremias S. Retina Specialists’ Evolving View on Biosimilars in AMD Treatment. The Center for Biosimilars. March 16, 2025. Available at: https://www.centerforbiosimilars.com/view/retina-specialists-evolving-view-on-biosimilars-in-amd-treatment. Accessed on June 2, 2025.
- Freed M, Biniek JF, Damico A, et al. Medicare Advantage in 2024: Enrollment Update and Key Trends. August 8, 2024. Available at: https://www.kff.org/medicare/issue-brief/medicare-advantage-in-2024-enrollment-update-and-key-trends/. Accessed on June 2, 2025.
- Congress’ Physicians Prep Strong Message Opposing Step Therapy in Medicare. AAO. June 27, 2019. Available at: https://www.aao.org/advocacy/eye-on-advocacy-article/congress-physicians-prep-strong-message-opposing. Accessed on June 2, 2025.
- National Survey on Innovator Biologics and Biosimilars. Biologics Prescribers Collaborative. August 8, 2023. Available at: https://biologicsprescribers.org/wp-content/uploads/2023/08/BPC_Patient-Choice_National-Survey-Report_August-2023.pdf Accessed on June 2, 2025.
