Wet age-related macular degeneration (wAMD) is a leading cause of treatable vision loss in elderly patients. Wet AMD vision loss is characterized by the overexpression of vascular endothelial growth factor (VEGF), which triggers choroidal neovascularization and the leakage of blood/fluid into the macula. Anti-VEGF treatments have led to remarkable vision gains in many patients with wAMD.
Ranibizumab, a humanized monoclonal antibody fragment was the first FDA approved anti-VEGF agent to demonstrate improvement in visual acuity in those with wet AMD. Previously, patients were treated with lasers including PDT which led to stabilization of vision but not vision gains in the majority of patients. Intravitreal anti-VEGF is now, without question, the standard of care for wAMD in the USA and worldwide.
The first ranibizumab biosimilar was recently FDA-approved for wAMD based on an extensive review of evidence, which included structural/functional characterization and clinical/safety analyses. In the global, randomized, double-masked, parallel phase 3 equivalence study of 705 patients with AMD with subfoveal CNV, patients treated with ranibizumab-renu monthly were compared to monthly reference ranibizumab. The overall data suggest that the biosimilar and reference ranibizumab have comparable efficacy, safety, and immunogenicity, and the similarity of all primary and secondary efficacy endpoints was maintained at all timepoints up to week 52. According to the manufacturer, the price of the biosimilar is 40% lower than the reference biologic and has the potential to expand access to patients.
What are your thoughts on using the FDA-approved ranibizumab biosimilar in your practice?
Well, we live in a free market system for the most part and therefore, the reimbursement points we get with each injection truly help. That being said, I do not and will not understand this company's decision to go head-to-head with Ranibizumab when the (let's face it) generic Bevacizumab are already a foregone conclusion with the studies to back up their efficacy. Had it been Ranibizumab vs. Aflibercept generics, we'd be talking......
We have begun to use Byooviz in our practice, as I agree with you, current anti-vegf costs will be unsustainable in the long-term future.
[~ @camc.org] price point is one thing, but safety and efficacy as the pivotal trial that led to FDA approval for the biosmilar provide a good foundation for clinicians to feel confident in using the product in their practice. I will continue to look at real world experience as increasing numbers of biosimilar injections are performed. As intravitreal injection providers, we have a high threshold for safety, and increasing use will provide more real world data to support the use of biosimilars in our patients with vitreoretinal disease.
driven if there are no new issues with the injections