Impact of Biosimilars in Ophthalmology

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

EP: 2.Interchangeability of Biosimilars in Ophthalmology

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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

EP: 8.Building Confidence in Biosimilars in Ophthalmology

Rishi P. Singh, MD: So, Michael, we talked a little bit about the studies and the trials that validate biosimilars, but tell us about how it really influences your daily practice. How does it impact you? How does it impact your patients? How about access to care for these individuals?

Michael A. Klufas, MD: Yes, great question. I think from a cost standpoint, we have to be somewhat conscious in 2023 [and] 2024 of cost. There are an increasing number of [patients with] age-related macular degeneration…and [patients with] diabetic macular edema, diabetic retinopathy…. So for sure, the biosimilars offer cost savings. So that’s definitely a factor to consider, especially as our clinics become busier and busier every year. And we also have to take account of this from the patient standpoint, whether there [are] co-pays or any other out-of-pocket costs, and kind of make a plan with the patient about what we can do that’s clinically effective, safe, and cost effective. I know our practice has used a fair amount of biosimilars now, and that first plunge into…integrating [them] in your practice, I think, takes a leap of faith. However,…one consideration we thought about is [that] many of the reference products are now in a prefilled syringe. If we were to switch to a biosimilar, it’s in a vial. We have standard operating procedures to make that a safe process in our practice, even when it’s repetitive. And also the data from the clinical trials and the mark of interchangeability from the FDA, we have a lot of confidence if this is given,…we can tell patients this is the same compound, it’s not a generic version, and we’re obtaining ranibizumab or another biosimilar from another manufacturer with good clinical evidence from the FDA involving hundreds of patients or even thousands of patients in clinical trials now.

Rishi P. Singh, MD: I agree. Obviously, we know that biosimilars have improved access to care significantly [and] reduced cost, in fact. We’ve even seen recently, as you mentioned, the price of ranibizumab dropping precipitously since its initial high back in the day, now to much lower values, almost 50% of what [it] used to be. And across the board in medicine, we know that biosimilars can [mean] huge cost savings to both health care plans and individuals who [are] facing these…costs as a rise in drug costs are happening. This is a way of addressing some of those drug cost issues.

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