Biosimilarity Between SB11 and Lucentis for nAMD Further Supported

Long-term results of a study comparing ranibizumab biosimilar SB11 vs reference ranibizumab (Lucentis; RBZ) on neovascular age-related macular degeneration (nAMD) show additional support for the biosimilarity ratified between SB11 and RBZ, according to British Journal of Ophthalmology.

graphic of the surface of the eye

This study was conducted to offer longer-term data on the efficacy, safety, immunogenicity, and pharmacokinetics (PKs) o SB11 compared with RBZ in patients with nAMD, a dominant global cause of visual impairment and blindness in people older than 50 years. Loss of vision can harm vision-related quality of like and is linked to a total annual direct cost of over $575 million. Biosimilar availability might be able to limit the socioeconomic burden of blindness triggered by nAMD.

The patient population consisted of patients age 50 and over with nAMD (n = 705) with 1 “study eye.” The intervention consisted of 1:1 randomization to monthly intravitreal injection of 0.5-mg SB11 or RBZ every 4 weeks from baseline to week 48.

First, a multicentered, randomized, double-masked, parallel-group, phase 3 equivalence study was conducted. Main outcome measures consisted of visual efficacy end points, safety, immunogenicity, and PK up to 52 weeks.

Baseline and disease characteristics were analogous between treatment groups. Of 705 randomized participants (SB11, n = 351; RBZ, n = 354), 634 participants (SB11, n = 307; RBZ, n = 327) fulfilled the study until week 52.

Formerly reported equivalence in primary efficacy stayed stable up to week 52 and was comparable between SB11 and RBZ. The adjusted treatment difference among SB11 and RBZ in the full analysis set at week 52 of change from baseline in best-corrected visual acuity was −0.6 letters (90% CI, −2.1 to 0.9) and of change from baseline in central subfield thickness, −14.9 mcm (95% CI, –25.3 to –4.5).

Between SB11 and RBZ, respectively, the incidence of ocular treatment-emergent adverse events (TEAEs) (32.0% vs 29.7%) and serious ocular TEAEs (2.9% vs 2.3%) seemed comparable between treatment groups, and no new safety concerns were seen. The PK and immunogenicity profiles were analogous, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies, respectively.

The data also showed no clinically meaningful differences between SB11 and RBZ. Primary and secondary efficacy end points remained similar at all timepoints up to week 52, validating comparable longer-term efficacy aligned with the results from previously reported studies with RBZ for nAMD.

In terms of safety, the safety profile of SB11 looks to be true to the known RBZ profile, and no new safety concerns were recognized during the study period.

“TEAEs were mostly mild or moderate in intensity, and the majority of events was not related to the study treatment,” said the researchers.

It’s been observed that biosimilars in other fields of medicine can add to lowering health care costs and better patient access to therapies with approved labels. More research is needed to study the contribution of RBZ biosimilars to decreasing undertreatment in nAMD and advancing the visual outcomes in clinical practice.

To the best of the researchers’ knowledge, this is the first study to convey phase 3, week 52 follow-up data of ranibizumab biosimilar for nAMD treatment. However, they added that larger studies will be needed to see if small numerical differences found in the cumulative incidence of antidrug antibodies at week 52 that were within the known 1%-to-9% range for RBZ actually represent small immunogenicity result differences.

“In summary, the longer-term results of SB11 support the previously reported efficacy, safety, immunogenicity, and PK compared with RBZ in participants with nAMD, supporting its use as a safe and effective RBZ biosimilar,” concluded the researchers.

Reference

Bressler NM, Veith M, Hamouz J, et al. Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes. Br J Ophthalmol. 2023;107(3):384-391. doi:10.1136/bjophthalmol-2021-319637