Ophthalmology Biosimilars Show Similar Safety, Efficacy to Reference Eylea and Lucentis

Trial results presented at Euretina Congress 2023 supported the biosimilarity of a proposed biosimilar to aflibercept and an approved biosimilar to ranibizumab to their respective reference products based on immunogenicity profile, safety, efficacy, and pharmacokinetics.

Euretina was held in Amsterdam, the Netherlands, October 5-8.

Aflibercept

The results of a phase 3 trial for SB15, a proposed aflibercept (Eylea) biosimilar, were presented in 2 abstracts.^1,2 The double-masked, parallel-group, multicenter trial randomized 449 participants 1:1 to receive 3 monthly intravitreal injections of either 2-mg SB15 or the reference product. This was followed by treatment once every 8 weeks up to 48 weeks.

At 32 weeks, 438 patients were rerandomized to either continue on their treatment or switch from the reference product to the biosimilar. Results were presented up to 56 weeks. After being rerandomized, 219 patients continued on the biosimilar, 108 continued on the reference, and 11 switched.^1,2 Improvements from baseline in best corrected visual acuity (BCVA) were comparable between the groups, as were the safety, immunogenicity, and pharmacokinetics.¹

There are 2 ranibizumab biosimilars approved in the United States and 3 approved in the European Union.

Image credit: Artem Markin - stock.adobe.com

The mean BCVA letter score was 65.3 before the switch at week 32 and 65.8 after the switch at week 56 for the group of people who switched from the reference product to the biosimilar. In comparison, the group that stayed on the reference had a mean BCVA letter score of 65.2 at week 32 and 65.8 at week 56.²

“We are pleased to present the switching data of SB15 from reference aflibercept that continues to demonstrate its comparable clinical efficacy and safety in treating patients with nAMD [neovascular Age-Related macular degeneration],” Hyejin Kim, vice president and medical and lifecycle safety team leader at Samsung Bioepis, said in a statement.³ “We hope the study results also help allay concerns over safety and efficacy of biosimilars for their use in patients who were previously treated with reference product.”

Byooviz

Additionally, there were data on Byooviz, a ranibizumab (Lucentis) biosimilar.⁴ Byooviz was approved in the United States in September 2021 and launched June 2022⁵; it received marketing authorization in the European Union in August 2021.⁶

The post-hoc analysis of the phase 3 randomized, double-masked, parallel-group equivalence study included 705 patients who received monthly intravitreal injections of either 0.5-mg SB11 or the reference product for up to 48 weeks. The participants were 50 years or older with NAMD and active subfoveal choroidal neovascularization lesions.

The results showed no differences comparing the immunogenicity of the 2 products at week 52. The change from baseline in BCVA and central subfield thickness were not associated with antidrug antibody status. Mean (SD) serum ranibizumab concentrations were slightly lower in patients who were ADA positive compared with those who were ADA negative.

“These findings further support the biosimilarity of SB11 and [reference ranibizumab], with no new safety concern identified for SB11 vs [reference ranibizumab] associated with immunogenicity," concluded the study authors.

References

1. Woo SJ, Sadda S, Bradvica M, et al. Phase III randomized clinical trial comparing SB15 with reference aflibercept in neovascular age-related macular degeneration: 56-week results. Presented at: Euretina Congress 2023; Amsterdam, the Netherlands; October 5-8, 2023.

2. Sadda S, Woo SJ, Bradvica M, et al. Pre-to-post switching efficacy and safety assessments of SB15 (proposed aflibercept biosimilar) in neovascular age-related macular degeneration: findings from a post-hoc analysis of a phase III clinical trial. Presented at: Euretina Congress 2023; Amsterdam, the Netherlands; October 5-8, 2023.

3. Samsung Bioepis presents post-hoc analysis of phase 3 clinical trial for SB15, a proposed biosimilar to Eylea (aflibercept), at EURETINA 2023. News release. Samsung Bioepis. October 7, 2023. Accessed October 17, 2023.

4. Woo SJ, Kim MY, Oh I, Kim T, Bressler NM. Immunogenicity with ranibizumab biosimilar SB11 (Byooviz) and reference product Lucentis and association with efficacy, safety, and pharmacokinetics: a post hoc analysis of a phase III randomized clinical trial. Presented at: Euretina Congress 2023; Amsterdam, the Netherlands; October 5-8, 2023.

5. Hagen T. FDA approves first ophthalmology biosimilar: a ranibizumab. The Center for Biosimilars^®. September 20, 2021. Accessed October 17, 2023. https://www.centerforbiosimilars.com/view/fda-approves-first-ophthalmologoy-biosimilar-a-ranibizumab

6. Ranibizumab biosimilar (Byooviz) gains EU marketing authorization. The Center for Biosimilars^®. August 30, 2021. Accessed October 17, 2023. https://www.centerforbiosimilars.com/view/samsung-bioepis-byooviz-gains-ema-marketing-authorization