EURETINA 2026: Real-world evidence on retinal biosimilars

As real-world data on retinal biosimilars accumulates, the conversation among clinicians has shifted from whether these agents are comparable to the reference product to how they actually perform in everyday practice. Ashish Sharma, MD, founder and chair of the International Retina Biosimilar Study Group (Inter-BIOS), presented real-world evidence on aflibercept-ayyyh and FYB-201 (Ravegza) at EURETINA 2026, held 1-4 October in Vienna, Austria.

In this Q&A conversation with Ophthalmology Times Europe, Sharma—who is also consultant retina and director of clinical research at Lotus Eye Hospital and Institute in Coimbatore, India—discusses what the APEX and APEX-LT datasets show about long-term outcomes, what the evidence says about switching from reference products, and what still needs to happen before biosimilar access translates into broader patient access to anti-VEGF therapy.

Note: Transcript edited lightly for clarity and length.

OTE: As Inter-BIOS moves from regulatory approval data toward real-world evidence, what has been the most important shift in how clinicians think about biosimilars now compared with when aflibercept biosimilars first entered the market?

Ashish Sharma, MD: The biggest shift has been from asking whether biosimilars are scientifically comparable to asking how they perform in everyday clinical practice.

When retinal biosimilars first entered the market, there was understandably a degree of caution around extrapolation, switching and the possibility of unexpected safety signals with repeated intravitreal administration.

Today, we have moved considerably beyond that initial uncertainty. We now have increasing real-world experience across different retinal diseases, geographies and treatment settings. At Inter-BIOS, our objective has been to complement regulatory evidence with large, multicentre real-world datasets that clinicians can relate directly to their own practice.

I think the conversation is therefore becoming much more practical: Which patients are appropriate, how should we switch, what happens to treatment intervals, and can biosimilars help improve access without compromising outcomes?

OTE: Can you walk us through what the APEX and APEX-LT studies show about real-world outcomes with aflibercept-ayyyh?

Sharma: The APEX program is particularly valuable because it looks at aflibercept-ayyyh in the environment in which we actually treat patients.

Our early APEX study included 707 treatment-naïve eyes receiving 1,912 injections and demonstrated significant functional and anatomical improvements across retinal vascular diseases, with a favorable short-term safety profile.

The larger APEX safety dataset extends that experience to more than 52,000 intravitreal injections, allowing us to look much more closely at uncommon ocular safety events. The published APEX safety study found no new safety signal, which is important when clinicians are evaluating a new intravitreal biosimilar.

The APEX-LT work is another important step because clinicians need to know not only whether a biosimilar works initially, but whether visual, anatomical and safety outcomes remain consistent over longer-term real-world treatment.

I would emphasize that these are observational real-world studies and should be interpreted alongside the randomized comparative evidence. Taken together, however, the accumulating evidence is reassuring and consistent with the established biosimilarity of aflibercept-ayyyh.

OTE: Switching is one of the biggest open questions for biosimilars in practice. What does your real-world data show about outcomes in patients switched from the reference product to a biosimilar?

Sharma: Switching has probably been one of the biggest practical questions from retina specialists.

The important message from the evidence available so far is that a transition from the reference product to aflibercept-ayyyh has not identified a new efficacy or safety concern. The randomized comparative study included a transition from reference aflibercept to aflibercept-ayyyh and found no clinically meaningful differences after the switch.

Real-world data are now adding an important layer to this. In a separate 1,000-eye real-world analysis, 91% of eyes had switched from prior anti-VEGF therapy, with visual acuity remaining stable among switchers over the observed follow-up period.

What we still need is longer-term, larger and more diverse datasets to understand treatment intervals, durability and switching patterns in different healthcare environments. That is precisely where collaborative real-world evidence such as Inter-BIOS can make an important contribution.

OTE: Your multicentre data also covers FYB-201 (Ravegza). How does that experience compare with what you have seen with aflibercept-ayyyh?

Sharma: I would be cautious about making a direct head-to-head comparison because these are different molecules and different real-world datasets, rather than a randomized comparison between the two biosimilars.

Our FORCE experience with FYB-201 has been very encouraging. The original FORCE study provided multicentre real-world evidence across retinal vascular diseases, and our recent Middle Eastern extension provided additional experience with Ravegza in Saudi Arabia and Uptera in Jordan.

What I find particularly valuable is that we are seeing real-world experience accumulate across different biosimilars, different regions and different clinical settings.

For retina specialists, the broader message is that biosimilar adoption should be guided by the totality of evidence for each individual product, rather than assuming that all biosimilars are identical simply because they belong to the same category.

OTE: Access and cost have been central to the biosimilar conversation. Based on Inter-BIOS’ international data, is real-world uptake actually improving patient access to anti-VEGF therapy, or are there barriers still slowing that down?

Sharma: I believe biosimilars have the potential to improve access, but we should be careful not to assume that approval automatically translates into access.

Cost is certainly an important component, but access is influenced by many factors—reimbursement policies, physician confidence, hospital formularies, procurement systems, patient awareness and local healthcare economics.

What we are seeing globally is a very diverse picture. In some markets, biosimilars are already becoming an important part of retinal practice; in others, adoption remains slower.

This is why I think real-world evidence is so important. If we can demonstrate consistent clinical outcomes, safety, switching experience and durability, while creating a more economically sustainable treatment environment, then biosimilars can become an important tool for expanding access to anti-VEGF therapy.

Ultimately, the goal is not simply to increase biosimilar utilization. The goal is to enable more patients who need anti-VEGF therapy to actually receive and continue appropriate treatment.

Ashish Sharma, MD

E: drashish79@gmail.com

Sharma is founder and chair, International Retina Biosimilar Study Group (Inter-BIOS), and consultant retina and director of clinical research at the Lotus Eye Hospital and Institute in Coimbatore, India.