Biosimilar Ranibizumab Shows Similar Efficacy to Innovator Drug in nAMD Treatment

Article

An analysis of real-world data suggests intravitreal injection of biosimilar ranibizumab in a loading dose followed by a PRN protocol is a viable strategy for treating patients with nAMD.

Close-up of eyeball │ Unsplash/v2osk

Credit: Unsplash/v2osk

Real-world evidence indicates that biosimilar ranibizumab is similarly effective to innovator ranibizumab in treating neovascular age-related macular degeneration (nAMD), with improvements seen in both visual and anatomical outcomes.1

Data from the multicenter, observational BALANCE trial demonstrated that both treatment groups maintained improvements in best-corrected visual acuity (BCVA) over 52 weeks, while central macular thickness (CMT) significantly improved at all time points.

“As biosimilar ranibizumab is much cheaper than the innovator product, its adoption on a larger scale can ensure better utilization of resources in the treatment of retinal and ophthalmic disease in the long run without comprising the quality of visual and anatomic outcomes in patients,” wrote the investigative team.

Treatment with anti-vascular endothelial growth factor (anti-VEGF) molecules has resulted in significant improvements in nAMD prognosis, with lead investigator Debdulal Chakraborty, MBBS, department of vitreoretinal services, Disha Eye Hospitals, noting their introduction and use have reduced certain blindness in nAMD patients. Previous literature had demonstrated the ability of ranibizumab to significantly improve visual acuity in this population, but the high cost of the therapy has proven to be a major obstacle in widespread public use.

As a result, a safe and effective biosimilar compound could help effectively treat the disease and lower the overall treatment cost at the same time. Chakraborty and colleagues performed a retrospective analysis of treatment-naive patients who underwent intravitreal injection of innovator ranibizumab or biosimilar ranibizumab between March 2021 - October 2021 at a group of eye hospitals in eastern India.

After a loading dose of 3 intravitreal injections, investigators used a pro re nata (PRN) treatment regimen and patients were followed up for 12 months from the day of the first injection. The primary outcome measure for the analysis was the change in visual acuity at month 3 and at the 6, 9, and 12-month time points between innovator ranibizumab and biosimilar ranibizumab. Criteria for inclusion were met by 164 eyes (60.74%) of a potential 321 eyes, with 87 treated with innovator ranibizumab and 77 treated with biosimilar ranibizumab.

There were no statistically significant differences regarding demographic characteristics and baseline parameters between the two groups. The baseline BCVA was 0.57 ± 0.27 logMAR in the innovator ranibizumab group and 0.61 ± 0.25 in the biosimilar ranibizumab group.

According to the analysis, both biosimilar and innovator ranibizumab led to significant improvements in BCVA. Compared to baseline, innovator ranibizumab-treated patients showed significant improvements in BCVA after 3 months (0.27 ± 0.22; P <.0001), 6 months (0.34±0.23; P <.0001), 9 months (0.39 ± 0.25; P <0.0001), and 12 months 0.41 ± 0.23 (P <.0001).

The analysis showed biosimilar ranibizumab-treated eyes also had significant improvements in BCVA at 3 months (0.24 ± 0.16; P <.0001), 6 months (0.27 ± 0.16; P <.0001), 9 months (0.34 ± 0.17; P <.0001), and 12 months (0.38 ± 0.18; P <.0001), compared to baseline. Investigators noted a comparative analysis between the groups showed no significant differences at any of the time points.

Further, the data showed both innovator and biosimilar ranibizumab injections resulted in significant improvements in CMT among nAMD eyes. Similar to BCVA, there were no significant differences observed in CMT improvement between the two treatment groups at any time point. There were no significant differences observed between the two groups regarding improvements in IRF and SRF levels at any time point.

Results showed the required number of doses of innovator ranibizumab and biosimilar ranibizumab was similar over the 12-month study period. There were no adverse side effects, such as intraocular inflammation or endophthalmitis, found in any patients in the study, although the study was not powered to comprehensively analyze safety.

Per the recent approval of SB11 by the US Food and Drug Administration (FDA), Chakraborty and colleagues suggested the potential for the introduction new era in the use of biosimilars for the treatment of retinal vascular diseases.The overall improvement seen in patients with nAMD in the current study helps provide additional real-world data on the safety and efficacy of biosimilar ranibizumab.

“Given the financial constraints of long-term treatment with anti-VEGF agents, the use of biosimilars with a good safety and efficacy profile, along with a PRN or observe-and-treat strategy, following 3 loading doses, strict follow-up, and timely reinjections can help minimize the number of injections without losing treatment benefits in eyes with nAMD in resource-poor settings,” they wrote.

References

  1. Chakraborty D, Mondal S, Boral S, et al. Biosimilar versus InnovAtor MoLecule of RAnibizumab in Neovascular Age-Related MaCular DEgeneration (The BALANCE Trial): Real-World Evidence. Clin Ophthalmol. 2023;17:1067-1076. Published 2023 Apr 8. doi:10.2147/OPTH.S407219
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