Samsung Bioepis Reports Equivalency for Ranibizumab Biosimilar

Samsung Bioepis announced that its ranibizumab biosimilar (SB11) demonstrated equivalent efficacy, safety, and immunogenicity to the reference product (Lucentis) in a 24-week phase 3 clinical trial involving patients with neovascular age-related macular degeneration (nAMD).

Investigators evaluated the improvement in best corrected visual activity, a measurement of vision impairment, at week 8, finding the least squares (LS) mean change for SB11 to be 6.2 versus 7.0 letters for reference ranibizumab (90% CI), which was within the predefined margin of ± 3 letters.

At week 4, the LS mean change for central subfield thickness (CST), the depth of the small curve in the retina where vision is most acute, was also analyzed. The CST change for SB11 was —108.4 μm, which was comparable to reference ranibizumab with a CST change of –100.1 μm (95% CI), and well within the predefined margin of ± 36 μm.

The incidence of drug-related adverse events was 66% for SB11 and 66.9% for reference ranibizumab. Antidrug antibody formation was also low, with a 3.0% incidence for SB11 versus 3.1% for the reference product. In addition, pharmacokinetic serum concentrations were found to be comparable.

To read more, visit The Center for Biosimilars.