Building Confidence in Biosimilars in Ophthalmology

EP: 1.Overview of Biosimilars and the Approval Process in Ophthalmology

EP: 2.Interchangeability of Biosimilars in Ophthalmology

EP: 3.Impact of Biosimilars in Ophthalmology

EP: 4.Challenges With Off-Label Bevacizumab Use in Retinal Diseases

EP: 5.Rationale for Shorter Endpoints in Biosimilar Clinical Trials

EP: 6.Current Anti-VEGF Biosimilars Approved for Ophthalmologic Conditions

EP: 7.Biosimilars in Ophthalmology: Challenges, Access, and Patient Assistance Programs

Now Viewing

EP: 8.Building Confidence in Biosimilars in Ophthalmology

Rishi P. Singh, MD: Talk to me a little bit about physician/patient communication. How do you best talk to your patient? I don’t want to say sell, but I want to say in a nice way, how do you convince your patient that this is the right move for them, and they should make consider this among the therapies they’re getting right now?

Michael A. Klufas, MD: I think every case is a physician-patient relationship. In my experience, typically with intravitreal products, there is some more direct consumer, patient advertising out there, but most of the time, patients are putting their confidence in the physician to choose a product that’s going to improve their vision, hopefully, be clinically efficacious and be safe and cost-conscious as well. So my preference is to have a unlabeled biosimilar rather than an off-label compound like bevacizumab. I just feel there is a little bit more safety there from the studies and from real-world evidence. So I definitely use it in treatment-naive patients, and I tell them, “It’s not a generic, it’s from a different manufacturer, similar, same compound from a preclinical assessment” and all these factors. And usually, patients don’t have much of an issue with a biosimilar. I haven’t encountered a lot of resistance, especially because they may be familiar with generic drugs and I emphasize to them, “This is not a generic, it’s quite a different production process” and go from there, and then we make the decision together.

Rishi P. Singh, MD: I think to your point, having that conversation that this is not off-label, that this is produced in the same production facilities that major branded drugs are approved for and the same quality levels are established there, so there’s no concern. It has been used in thousands of patients prior to use, so it has been very safe and effective, and it would save [money], obviously, if you’re on a primary and secondary insurance plan, sometimes the secondaries don’t always cover everything. This is a way of saving that delta for that as well. So that’s another option too. Lastly, before we close, what advice do you have for physicians, maybe [they haven’t been using biosimilars] in some ways? Obviously, there’s a patient part, [which we] just talked about, but what about for the physician side of it? What’s the confidence they need to incorporate [it] in their practices?

Michael A. Klufas, MD:Good question. I think many of these companies do have medical science liaisons. They’re happy to provide you with the major trials. I have looked at all these with SB11, the COLUMBUS-AMD [age-related macular degeneration] [trial], and I think there’s a misperception sometimes that, “Oh, there was a 50-patient study that led to approval.” It’s hundreds of patients. So, I think that’s one thing, looking that the data is good or even monographs provided by the company to show the nearly identical gains in vision and also corresponding OCT [optical coherence tomography] [and] CST [central subfield thickness] outcomes. I think one thing we didn’t talk about is extrapolation. This is one thing that’s a little different with biosimilars. Usually there’s a study done in 1 condition and then by the process of extrapolation, they get approval for all the indications of the reference product. Typically, the studies I’ve seen have been done in neovascular age-related macular degeneration and then by extrapolation, they receive approval for macular edema following RVO [retinal vein occlusion], myopic CNV [choroidal neovascularization], and sometimes a DR [diabetic retinopathy] or a diabetic macular edema. And then I think peer-to-peer exchanges like this are highly helpful. If you have a peer you trust who’s using this product, as with many other things, when we have [adverse] effects and ophthalmology, we’re talking to peers, “How do you manage this, how do you do that?” [If you have a peer] or peer group that’s using biosimilars, I would reach out to them and see what their experience has been from a clinical standpoint and also a reimbursement standpoint and the patient satisfaction standpoint.

Rishi P. Singh, MD: That’s great. Good to hear that. I think, again, I would say the same thing with cases. Cases can be very helpful to get the point home. I think obviously aggregate data, big data in this area could be very helpful in explaining the case for biosimilars. It’s very valuable, certainly, to see those that research being performed in these areas. Really great to see that hopefully come into practice soon that we can share those with our providers as well. So great. Well, I want to thank you, Michael, for your excellent conversation [about] biosimilars. I want to thank you all for watching this Peers & Perspectives titled, “Inspiring Biosimilars With Treatment of Retina Vascular Disease.” I hope you found this helpful, where we really explored all aspects of biosimilars, including the approval process, how they get into our hands, how there are benefits to both patient and providers, and how we adopt these into clinical practice to help our patients see better each and every day. Thank you very much for your attention.

Michael A. Klufas, MD: Thank you, Rishi.

Transcript is AI-generated and edited for clarity and readability.