Exploring Biosimilars for the Treatment of Retinal Vascular Diseases - Episode 6
Rishi P. Singh, MD; and Michael A. Klufas, MD, provide an overview of the 2 currently available ophthalmology biosimilars, ranibizumab-eqrn and ranibizumab-nuna, as well as discuss which patient populations will benefit from these treatments.
Rishi P. Singh, MD: We have 2 biosimilars now—[with] many more in the making—2 FDA-approved biosimilars. There’s ranibizumab-eqrn or ranibizumab-nuna. Michael, can you compare and contrast their indications as it currently stands a little bit?
Michael A. Klufas, MD: Great question. Perhaps we’ll start with ranibizumab-nuna. This was actually the first ranibizumab produced biosimilar from a company, Biogen, who had experience with biosimilars in the rheumatology and oncology space. This particular biosimilar is approved for age-related macular degeneration and retinal vein occlusion, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. And it’s available in the 0.5 mg dose. Of note, there is not a 0.3 [mg] dose produced from Biogen, and so there is not approval for diabetic macular edema or diabetic retinopathy. The other currently approved biosimilar [of] ranibizumab, ranibizumab-eqrn, this product is approved for the same indications as the other biosimilar, so age-related macular degeneration, macular edema following retinal vein occlusion, myopic choroidal neovascularization as well as diabetic macular edema and diabetic retinopathy. For the diabetic disease, the dose is 0.3 [mg], as we are used to from the reference product. The other big difference is ranibizumab-eqrn has been granted interchangeability from the FDA. So for the reasons we discussed earlier, it may be substituted for the reference product with no difference in safety and clinical efficacy.
Rishi P. Singh, MD: Absolutely, I think that’s a big difference there between the kind of broad indication with ranibizumab-eqrn vs ranibizumab-nuna. While they’re both available to us, they have very different applications or indications right now. Let’s walk through your thought process, and I’ll give you mine, about where you see biosimilars as being valuable for your patient population. So maybe you can give me kind of the ideal patient, is it a treatment-naive patient, is it a patient with high treatment burden, is it a patient prone to nonadherence due to cost? What would be the ideal patient you think in your practice where you’re applying it today?
Michael A. Klufas, MD: It’s a really interesting question and especially how a physician may want to integrate a biosimilar in their practice. So I think there are a couple approaches. I have used both of these biosimilars, and I think the first time you use a new product, you’re [asking] “Is it going to be the same thing?” We’ve seen clinical trials, we’ve seen the safety [indications], but having done thousands of doses now, in my mind personally and based on the data, it acts the same as the reference ranibizumab. So I think if someone is experienced with using ranibizumab in the past, they could definitely try it on a treatment-naive patient and expect to see the same response as they’ve seen with the reference product. And that would probably be a good foray into introducing a biosimilar into your practice. We’re talking about cost, and if someone’s on a reference ranibizumab, they could be substituted to a biosimilar ranibizumab and you could also observe a similar effect there that could probably give you confidence that you’re going to see the same clinical effect in that patient in terms of treatment interval and anatomic outcomes. In terms of difficult to treat patients, we do have other agents available. Ranibizumab is a great compound. It’s probably the least inflammatory compound we have out in the market along with other drugs as well. [With] a difficult-to-treat patient, it’s totally reasonable to try a biosimilar, although sometimes we’re reaching for some other medications because ranibizumab or others have not worked in the past.
Rishi P. Singh, MD: I would agree with you that I think it’s not the high-frequency treatment patient population I’d be giving this to; it’d be the patient who’s doing well on the reference product, right? Who can potentially get a lower cost overall for what we’re delivering to them through that process. And that would be the way I would apply it. I think…treatment-naive patients are fine as much as treatment experienced patients. And certainly that’s an option to start with that drug potentially and save the patient and your practice some cost with the very similar product into the market and what we can hopefully achieve.
Transcript is AI-generated and edited for clarity and readability.