Data Confirm Biosimilar Ranibizumab Non-Inferiority as Myopic CNVM Treatment

Biosimilar ranibizumab (Razumab) is clinically equivalent to its innovator counterpart (Lucentis/Accentrix) for treating myopic choroidal neovascular membrane (mCNVM), a leading cause of vision impairment in younger adults, according to compelling evidence from a new multicenter, real-world study.¹ The findings, published in Clinical Ophthalmology, offer crucial support for payer adoption of biosimilars as cost-effective, high-quality alternatives, particularly in resource-constrained healthcare systems.

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Rationale: Addressing the Real-World Evidence Gap

The BRIM Study was conducted to compare the efficacy and safety of the 2 molecules in a real-world setting. While biosimilars are approved based on high similarity to their reference products, head-to-head comparative data for specific, less-common indications like mCNVM often remain scarce.

"In recent years, biosimilar versions of ranibizumab have emerged as more affordable therapeutic alternatives, particularly in low- and middle-income countries," the study authors noted. However, the researchers emphasized that despite increasing use, comparative data in this specific patient population was lacking. The research aimed to "provide evidence that may guide treatment decisions and inform healthcare policy in regions where cost remains a significant barrier to the use of anti-VEGF therapy."

This retrospective, multicenter study included 80 eyes of treatment-naïve patients with mCNVM who were followed for a minimum of 12 months. Patients were divided into 2 cohorts: 38 eyes received innovator ranibizumab (Group A), and 42 eyes received biosimilar ranibizumab (Group B). The treatment regimen for both groups followed a flexible, pro re nata protocol guided by disease activity observed on optical coherence tomography.

The included participants were adults, with the mean (SD) age of patients in the innovator group being 41.21 (7.33) years and the mean age of patients in the biosimilar group being 42.32 (3.92) years. The groups were well-matched in terms of demographics, with the mean refractive error being highly myopic in both cohorts (innovator, –10.33 [4.8] D; biosimilar, –11.11 [3.75] D).

The primary outcome was the change in best-corrected visual acuity (BCVA) at 12 months. The study demonstrated non-inferiority between the two treatment arms. Patients receiving innovator ranibizumab experienced an improvement in mean BCVA from 51.0 (16.5) ETDRS letters at baseline to 64.5 (5.5) letters at 12 months. Similarly, patients receiving biosimilar ranibizumab saw an improvement from 52.5 (16.5) letters to 64.5 (4.5) letters. The difference in visual acuity between the two groups was not statistically significant (P > .05). Anatomical outcomes, measured by central macular thickness (CMT), also showed similar reductions.

In the innovator cohort, mean CMT decreased from 332.03 (39.22) µm to 268.32 (18.78) µm at 12 months, while the biosimilar cohort experienced a comparable reduction from 315.03 (44.20) µm to 271.12 (20.39) µm. This equivalence extended to the treatment burden: patients in the innovator group required a mean of 2.68 (0.51) µm injections over the year, compared to 2.71 (0.49) µm injections for the biosimilar group. This comparable injection frequency confirmed the similar durability and efficacy of both treatments under a PRN protocol.

Furthermore, the safety profiles were equivalent, with both groups maintaining stable intraocular pressure over the 12-month period, and researchers reported that no serious ocular or systemic adverse events were noted in either group during the course of the study.

While the study is robust due to its multicenter, real-world design, the authors acknowledged a few limitations. Because the study was retrospective, long-term complications, such as the progression of chorioretinal atrophy or recurrence patterns, could not be fully assessed due to the relatively short 12-month follow-up period. Furthermore, the findings are specific to the mCNVM indication, and the authors cautioned that extrapolation to other retinal diseases should only be done when supported by dedicated data.

References

1. Chakraborty D, Sinha TK, Sinha S, et al. Biosimilar versus innovator ranibizumab in myopic CNVM: comparative real-world outcomes—the BRIM study. Clin Ophthalmol. 2025:19:3741-3747. doi:10.2147/OPTH.S549744