Does ranibizumab biosimilars fare as well in macular neovascularisation?

Abstract

To evaluate the effectiveness and safety profile of Ranibizumab Biosimilar in Macular Neovascularisation and compare outcomes with patent Ranibizumab.A retrospective analysis during the period 2017-2020 was conducted at a tertiary eye care centre in South Kerala on patients with wet AMD who had received Razumab, a biosimilar of Ranibizumab as a loading dose followed by PRN schedule. This was compared to a similar data obtained from patented Ranibizumab (Lucentis) during the same period. Endpoints analyzed included improvement in BCVA, proportion of patients with persistent IRF/SRF and complications at 1 year. Of 164 eyes analyzed 76 eyes received Razumab and 88 eyes received Lucentis with 32% and 50% males in each group. After the loading dose both drugs showed similar efficacy and the final vision (median logmar; 0.24 vs 0.17; p 0.189), presence of residual CME (31.6% vs 18.2%; p 0.469) and SRF (57.9% vs 61.9%; p 0.796) were similar in both groups at 12 months. The mean number of injections was 8 in the Razumab group comparable to Lucentis (6.4). Acceptability and less drop outs were seen in Razumab patients compared to Lucentis. Though some eyes developed mild uveitis (4.3%) with one of the initial batches of Razumab, it was not evidenced later. No other safety concerns or side effects were reported with the biosimilar.The Biosimilar Razumab is as effective as the patent molecule in reducing macular fluid and improving visual acuity in patients with macular neovascularization over 1 year on a PRN schedule. Being cheaper it is a safe alternative for patients who often need long term management.