Biosimilar Ranibizumab Displays Comparable Safety, Efficacy to Lucentis

Intravitreal injection of innovator ranibizumab (Lucentis) and biosimilar ranibizumab (Razumab) displayed similar efficacy and safety in the eyes of Indian patients with neovascular age-related macular degeneration (nAMD), according to a study published in Clinical Ophthalmology.

No significant differences were found in either the primary or secondary end points, demonstrating the biosimilarity between the originator and biosimilar products.

Researchers of the study noted that “FDA approval of SB11, a biosimilar ranibizumab, is perhaps the beginning of a new paradigm in the use of biosimilar ranibizumab in the treatment of retinal vascular disease in general and nAMD in particular” due to the financial savings and safety and efficacy profile of the drug.

Ranibizumab products are anti–vascular endothelial growth factor (VEGF) agents that are used to treat several ophthalmic conditions, including nAMD, diabetic retinopathy, macular edema, and myopic choroidal neovascularization.

Researchers were trying to observe the treatment outcomes of Lucentis vs Razumab in a retrospective observational study among patients with nAMD who were administered 3 loading doses. Primary outcome measures were change in best corrected visual acuity (BCVA) and central macular thickness (CMT) in addition to safety analysis. Secondary outcome measures were subretinal fluid (SRF) and intraretinal fluid (IRF) changes. The BCVA was evaluated using value scores from the Logarithm of the Minimum Angle of Resolution (logMAR) chart.

nAMD is a major contributor to vision loss among people over 50, with prevalence increasing constantly with age. It’s been estimated that the number of nAMD-afflicted patients will reach 288 million by 2040.

“Application of anti-VEGFs has significantly reduced almost certain blindness and has resulted in improved visual acuity in nAMD patients,” the researchers wrote. Currently, there are no comparative studies displaying the efficacy of the biosimilar with the innovator molecule with up to 12 months follow up.

In the study, inclusion criteria were confirmed in 164 (60.74%) eyes and a total of 87 eyes were treated with the innovator and 77 with the biosimilar.

The baseline BCVA was a mean (SD) logMAR value of 0.57 (0.27) in the innovator group and 0.61 (0.25) in the biosimilar group. At 3, 6, 9, and 12 months, the mean (SD) logMAR value in the innovator group was 0.27 (0.22) (P < .001), 0.34 (0.23) (P < .0001), 0.39 (0.25) (P < .0001), and 0.41 (0.23) (P < .0001), respectively. In the biosimilar group, the mean (SD) baseline logMAR value was 0.24 (0.16) at 3 months, 0.27 (0.16) at 6 months, 0.34 (0.17) at 9 months, and 0.38 (0.18) at 12 months (P < .0001 for all).

The baseline CMT was 420.39 (54.45) μm in the innovator group and 47.82 (53.07) μm in the biosimilar group. At 3, 6, 9, and 12 months, the CMT in the innovator group decreased to 258.28 (20.4) μm, 268.38 (19.5) μm, 269.51 (32.41) μm, and 278.28 (16.56) μm, respectively (P < .0001 for all). In the biosimilar group, the CMT dropped to 258.84 (17.47) μm at 3 months, 265.69 (17.29) μm at 6 months, 273.64 (23.13) μm at 9 months, and 283.09 (19.66) μm at 12 months (P < .0001 for all).

Both fluid compartments (SRF and IRF) displayed similar improvement starting from month 3 after the first 3 loading doses. The comparable efficacy of the originator to that of the biosimilar is further supported by a similar number of injections needed by the 2 drugs over the same period to reach similar clinical improvement and a similar profile of adverse events in both groups.

Then, researchers highlighted that past short-term results are in support of the results seen in this study. Razumab is around 30% to 40% less expensive than Lucentis in India. A PRN regimen with strict follow-up in resource-poor settings can offer comparable results with much reduced expenses if a fixed or a treat-and-extend regimen is not available. An additional reduction in the expenses can be brought about with the use of BRM.

Some limitations of the study included its retrospective design and pro re nata protocol after 3 loading doses and a fairly small data set which may have made it difficult to comment on adverse events.

The researchers concluded with “long-term prospective studies will enable us to better understand the efficacy and safety of BRM in nAMD management.”

Reference

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. doi:10.2147/OPTH.S407219