Retina Specialists’ Evolving View on Biosimilars in AMD Treatment

Retina specialists have been cautious about adopting ranibizumab biosimilars, not due to efficacy concerns but because of cost-driven mandates like step therapy, raising fears that biosimilars will be forced upon them rather than remaining a choice. However, with growing experience, the field is adjusting.

According to Paul Hahn, MD, PhD, FASRS, a retina specialist and vitreoretinal surgeon at NJ Retina and a board member of the American Society of Retina Specialists, the upcoming aflibercept biosimilars may face a smoother integration, especially as insurance and cost considerations push patients away from branded Eylea.

While real-world data confirms biosimilars' safety and effectiveness, the main concern is whether specialists will retain autonomy in treating age-related macular degeneration (AMD) and other retinal diseases. As more anti-vascular endothelial growth factor (VEGF) biosimilars enter the market, ongoing clinical experience will be key to building physician confidence.

Transcript

Based on your experience, how do retinal specialists perceive the ranibizumab biosimilars currently available on the market, and how appropriate do they consider them for treating patients with wet AMD?

People, and doctors in particular, are often very resistant or wary of change. When there's a new option on the market, if it doesn't fit their profile of what they're looking for, such as a new mechanism of action or a specific advantage, doctors may be a little bit wary of what that means, such as the case with biosimilars.

I think when biosimilars first became part of a consideration in the retinal armamentarium, there was a lot of hesitation around these. 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, but rather we're used to thinking about what works best for our patient.

It's a different mindset along the same lines. I think there's concern from a physician standpoint about how these biosimilars will be forced upon us as physicians. Right now, we like to treat our patients according to what medicine we think is best for them, but more and more there are insurance mandates that require us to use what is often the cheaper medicine First, what we call step therapy, or what some people have referred to as a fail-first approach, allows us to only use other therapies if they fail the less expensive drugs first.

With that history of step therapy mandates, I think there's a lot of hesitation to incorporating step therapy and biosimilars because of this concern that it's going to be something that's forced upon us.

What are your thoughts on the upcoming entry of multiple aflibercept biosimilars into the US market, and how do you think they will impact access to care for patients with AMD ?

The entry of ranibizumab biosimilars has accustomed many retina specialists to the fact that biosimilars are now here, and aflibercept biosimilars may have an easier time at being incorporated. Certainly, many patients are on the aflibercept reference product, Eylea, and as patients need to be transitioned away from Eylea, either because of cost considerations, insurance mandates, or for whatever other reason, I think those aflibercept biosimilars are going to be one of the options again. I think for biosimilars in general, there's always going to be a cost consideration and a concern for retina specialists that cost is going to trump efficacy in treating patient disease, but I think what we'll all agree is that it's great that we have options for our patients. If biosimilars provide additional options for our patients, that's fantastic.

Right now, in the beginning of 2025, we are seeing a lot of different events come into play, which is limiting access from retina specialists to therapies that they need. Along those same lines, having different options available, including biosimilars, is very important. As with ranibizumab biosimilars, I think, the importance is how these biosimilars, including the aflibercept biosimilars, are pushed onto the retina specialists, whether it's something that the retina specialists maintain choice in administering or it's something that they are mandated to start first before trying a drug that the retina specialist may think is better for that patient in front of them.

What kind of evidence do you think is needed to make retinal specialists feel comfortable enough to regularly prescribe anti-VEGF biosimilars to their patients with AMD and other retinal diseases?

The burden of approval for biosimilars is different than the reference product. The clinical trial pathway is slightly different. Utilization of these biosimilars and real-world experience identifying that these biosimilars are effective and safe is going to be important, and we've seen that.

With the biosimilars on the market, we have seen that they are effective and that they are safe. In a recent database study that I've recently performed, we saw that in 2023, biosimilars in this database accounted for about 3% of utilization. And in 2024, it increased to about 10% of utilization.

Whether retina specialists are becoming more comfortable using them or they're being forced to use them more often is unclear from that study. But certainly, there's increased utilization of biosimilars. With that, as we hopefully learn that they are indeed safe and effective, I think retina specialists will feel more comfortable.