Tony Hagen is senior managing editor for The Center for Biosimilars®.
Results up to week 52 in the phase 3 study show that primary end points were met for best corrected visual acuity and central subfield thickness.
One-year results of a phase 3 study of a proposed ranibizumab biosimilar (SB11) in patients with neovascular age-related macular degeneration have shown equivalence in efficacy and pharmacokinetics (PK), as well as comparable safety and immunogenicity to the reference product, according to Samsung Bioepis.
Results of the study will be presented at the American Academy of Ophthalmology 2020 Virtual meeting from November 13 to 15, 2020.
Investigators enrolled 705 patients and said that 634 patients completed the study up to week 52. They said that clinical end points, defined as changes from baseline in best corrected visual acuity (BCVA) at week 8 and central subfield thickness (CST) at week 4, were met.
Long-term efficacy, safety, PK, and immunogenicity were secondary end points, and findings were comparable between SB11 and the reference product (Lucentis).
In the randomized, double-blind, multicenter study, the 8-week mean change in eye chart letters read correctly from baseline in BCVA at week 8 was –0.8 letters (90% CI, –1.8 to 0.2) between SB11 and reference ranibizumab. The mean change from CST baseline at week 4 was an adjusted treatment difference of −8 mcm (95% CI, −19 to 3 mcm) between SB11 and the reference agent.
The mean change from baseline in BCVA by week 52 was 9.79 letters for SB11 vs 10.41 letters for reference ranibizumab (difference: –0.62 [90% CI, −2.092 to 0.857]).
The mean change in CST was −139.55 mcm for SB11 compared with −124.46 mcm for reference ranibizumab (difference: −15.09 [95% CI, −25.617 to −4.563 mcm]).
Investigators said that PK, safety, and immunogenicity between the biosimilar candidate and reference product were comparable at all time points up to week 52.
In May 2020, Samsung Bioepis reported 24-week interim results from the same study.