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Advances in the Clinical Management of Diabetic Macular Edema and Age-Related Macular Degeneration - Episode 12

Biosimilars for DME and AMD

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Carl D. Regillo, MD, FACS, and Michael A. Klufas, MD, discuss the possible impact of biosimilars and share important considerations regarding cost and safety.

Carl D. Regillo, MD, FACS: Mike, we’ve had ranibizumab in our hands since 2006. The patent expired, and that’s led to companies developing biosimilar ranibizumab. One is right about to be in our hands. How do you anticipate this being used?

Michael A. Klufas, MD: Great question. It’s going to be a bit of paradigm shift. In essence, many companies—not just 1—now that the patent is up for Lucentis, or ranibizumab, are developing a clinically equivalent molecule and the regulation for these is quite different from a large phase 3 study. One is coming to the market soon. It’s known as ranibizumab-nuna [Byooviz], and we’re going to see how that fits into the treatment paradigm. The eye is a very sensitive organ. We’ve seen biosimilars in oncology and rheumatology, but we’ve got to remember these are biologic proteins that are created from cells. We have to see how these biosimilars will react in a space such as the eye where there can be inflammation.

Carl D. Regillo, MD, FACS: I’m going to call you out on that word equivalent. That’s why they’re called biosimilars: as you said, in the manufacturing process of a biologic, it’s not possible to get the identical molecule or product compared with the brand. As a field, you’re right. We have some concerns about safety. Biologics, the ones we’ve been using, have a small rate of inflammation. We’ve had episodes where there have been some outbreaks of inflammation with products. There’s some concern because of smaller trials, a shorter time frame, and making a biologic can be a bit finicky. We hope it’s going to be safe but the way I see it, we’re looking forward to using the new and improved biologics, something like faricimab which is more durable. I don’t have a strong interest in staying with the first-generation products. This means continuing to use the drug we’ve been using all along as a first-generation anti-VEGF. It’s not an advancement. I don’t think it benefits our patients other than for the total cost factor to perhaps be lower.

Michael A. Klufas, MD: The ophthalmology arena is interesting because we’ve compounded off-label bevacizumab which is always going to be the most value in terms of price. These biosimilars aren’t going to be able to compete on price with the label compound, the bevacizumab. We’ve got to see how it’s going to fit it into our treatment paradigm with an increasing number of patients who need these treatments year after year.

Carl D. Regillo, MD, FACS: You’re saying this doesn’t represent a significant cost savings?

Michael A. Klufas, MD: That’s my personal opinion.

Transcript Edited for Clarity