As the battle lines become better drawn for the next wave of biosimilar applications and approvals, ranibizumab is getting a lot of attention lately. The patent on Roche’s reference product Lucentis® is due to expire in 2022, and this drug earned approximately $1.8 billion in revenue in 2019.
On May 18, Samsung Bioepis announced continued progress in its goal of bringing SB11, its investigational ranibizumab biosimilar to the US market; interim results of its phase 3 trial in patients with neovascular age-related macular degeneration seems promising. The preliminary results of the randomized, double-blinded trial were announced in a press release, instead of being presented at the annual meeting of the Association for Research in Vision and Ophthalmology, which was cancelled due to the COVID-19 outbreak.
The international study comprised more than 700 patients (including those from the US), testing the biosimilar against the reference agent. The primary endpoints were best corrected visual acuity at week 8 and central subfield thickness at week 4. The researchers found the mean change (calculated as least squares) in best corrected visual acuity was 6.2 letters for SB11 and 7.0 letters for the reference product. The least squares mean change in central subfield thickness was −108.4 μm for SB11 and −100.1 μm for Lucentis. The researchers found the confidence intervals of the difference between the treatments in these two parameters were within the predefined equivalence margins. Therefore, they concluded SB11 yielded clinical outcomes that were not significantly different than the reference product.
In terms of safety, the biosimilar and the reference agent exhibited virtually the same incidence of treatment-emergent adverse events (66.0% for SB11, 66.9% for Lucentis). The incidence of antidrug antibody formation was also nearly identical (3.0% vs. 3.1%, respectively).
If SB11 is approved by the US Food and Drug Administration, Biogen will be Samsung Bioepis’ commercialization partner. A 351(k) filing is expected in 2020.