Positive Results for Aflibercept Biosimilars Seen at AAO 2022

Two posters presented at the annual conference of the American Academy of Ophthalmology (AAO) demonstrated positive phase 3 results for proposed biosimilars that reference blockbuster drug, Eylea (aflibercept).

A 32-week Analysis of SB15¹

The first poster showed an evaluation of the safety, efficacy, and immunogenicity of SB15, an aflibercept candidate developed by Samsung Bioepis, over the course of 32 weeks in patients with neovascular age-related macular degeneration (nAMD).

In total, 449 patients with treatment-naive nAMD were included and were randomized 1:1 to receive intravitreal injection of 2 mg of the biosimilar (n = 224) or the reference product (n = 225) for 48 weeks. At week 32, the patients in the reference product group were randomized 1:1 again to either stay on the reference product or switch to the biosimilar.

The primary end point was change from baseline in best corrected visual acuity (BCVA) at week 8. The secondary end points were the change in BCVA at week 32 and change from baseline in central subfield thickness at week 32. Overall, 97.6% completed week 32 of the study.

Equivalence was met for the primary end points, and no new safety signals were identified. The incidence and severity of treatment-evident adverse events (TEAEs) between the 2 products were similar up to week 32. Immunogenicity and pharmacokinetic (PK) profiles were similar between treatment arms.

“We hope that our continued efforts for data generation help ophthalmologists have better understanding of biosimilars, and their comparable efficacy, safety, immunogenicity, and PK profile to reference products,” said Jin Ah Jung, director and medical affairs group leader, Samsung Bioepis, in a statement from the company.

The final results from the study up to week 56 will be presented in the “near future” for additional long-term data on the comparable safety and efficacy of SB15 and the reference product.

The INSIGHT Study on MYL-1701P²

The second study looked at the patient outcomes of MYL-1701P, a biosimilar candidate developed by Momenta Pharmaceuticals and Viatris, a company developed through a merger between Mylan Pharmaceuticals and Upjoin.

INSIGHT aimed to assess the therapeutic equivalence between the biosimilar and the US and EU versions of the reference product in patients with diabetic macular edema. The primary end point was mean change in BCVA at week 8. Safety, tolerability, and immunogenicity were evaluated over 52 weeks of treatment.

The study population included 355 patients from 9 countries who were randomized 1:1 to receive the biosimilar (n = 179) or reference product (n = 176). The study produced an adjusted treatment difference of 0.04 letters (90% CI, –1.16 to 1.24) for the groups, showing therapeutic equivalence between the drugs.

TEAEs were comparable for the biosimilar and reference product groups (n = 138 vs 138). No meaningful differences regarding antidrug antibodies were observed. The authors concluded that the proportion of patients who had meaningful gains and losses in visual acuity were similar between the treatment arms and that the biosimilar was safe and well tolerated by patients.

In March 2022, Viatris announced that Biocon Biologics would take over Viatris’ entire biosimilar business.

Reference

1. Woo SJ, Sadda SR, Bradvica M, et al. SB15, a proposed biosimilar to aflibercept, in nAMD: 32-week results. Presented at: AAO 2022; September 30-October 3, 2022; Chicago, Illinois. Poster PO381.

2. Bressler SB, Barve A, Beckmann K, et al. MYL-1701P (proposed biosimilar aflibercept) compared to Eylea in DME: outcomes from the phase 3 INSIGHT study. Presented at: AAO 2022; September 30-October 3, 2022; Chicago, Illinois. Poster PO387.