Bridging Knowledge Gaps Regarding Biosimilars in the Treatment of Retinal Disorders


Carl D. Regillo, MD, and Jennifer I. Lim, MD, discuss how evolving understanding regarding bioequivalence and the safety of biosimilars may lead to their wider use in the treatment of retinal disorders.

Carl D. Regillo, MD: Biosimilars have been around for a few years in medicine, but then again, they are new to us. Are you concerned about knowledge gaps? Are you concerned about the retina specialists not understanding what a biosimilar is and how it’s tested? Any concerns?

Jennifer I. Lim, MD: Until I started delving into this and understanding how biosimilars are made, what the safety standards are, and what equivalence studies are done, I was skeptical myself. Having read and understood the SB11 results, the FYB201, and then the design of all these other biosimilars for ranibizumab and aflibercept, I feel much more comfortable. I look at the equivalence studies, and I see that the curves are sitting right on top of each other in terms of visual acuity improvement and OCT decrease. Even when you look at the secondary end points, they’re hitting right on the mark. That tells me I am comfortable with the equivalence. The second part is the safety, so we look at the SB11, we look at the FYB201, and we see that they carried out the safety beyond what was required by the FDA. So we have 1-year safety data. On top of that, the FDA is requiring careful reporting and adherence to the standards. And [we’re] also looking carefully at the AEs [adverse effects], comparing the biosimilar AEs that are coming out to what’s happening with the reference standard, so that if there is a signal, we’re going to see it. I think retina specialists need to understand that, and I think we need to read about it. We need to educate our peers so that we feel comfortable using this. The flip side is the patient. The patient must understand that this is not necessarily a generic, because sometimes generics have connotations that they might not be quite as good. We can tell them that these are biosimilar drugs that have the same potency, efficacy, and safety, and [they] underwent rigorous testing.

Carl D. Regillo, MD: To be honest, I had to do a little homework for this event, because I, too, had those knowledge gaps. I didn’t precisely know the developmental path. I’ve been doing clinical investigations for trials of these reference products we’ve been using through the years, so I’m very familiar with the traditional biologic process. Some of the biologics that have been introduced have had unexpected intraocular inflammation problems. There is some concern, or a general heightened awareness, [that] the eye is a sensitive organ, and inflammation can be disastrous. Not always, but it can be. We saw that with an FDA-approved product. Any biologic that’s new to us in retina, people are going to be cautious at first and be scrutinizing not only the clinical trials, but also that postmarketing surveillance.

Jennifer I. Lim, MD: Exactly. That’s why it’s going to be key how we frame this. How do we present it to our patients? We must present it in a positive light because there’s this nocebo effect. We always talk about the placebo, but we don’t really talk about the nocebo effect.

Carl D. Regillo, MD: What is nocebo?

Jennifer I. Lim, MD: The nocebo effect is, if you think something is not going to work as well, you will have this negative effect. Technically, you can get this. So how would this work with a biosimilar? Somebody could think, "the biosimilar may not work as well," and any side effect they have, they’ll attribute it to the biosimilar. That could be on the physician side, or it can be on the patient side. We must be careful that when we report these effects out, and when we present these to our patients, we’re cognizant of that. Again, positive framing, and explaining to the patient that this is an equivalent drug. That’s not to say I’m not going to be open to the fact that they do have a side effect, or if we see IOI [intraocular inflammation], of course we’re going to be on the lookout for that, but in general, realize that you have to be open-minded about this and give it a fair shot.

Carl D. Regillo, MD: Trust the process?

Jennifer I. Lim, MD: Trust the process.

Transcript edited for clarity

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