On 6 November 2025, Biocad announced that it is commencing enrolment for a Phase III clinical trial of BCD-281, biosimilar to Roche’s Ocrevus® (ocrelizumab). The study, to be conducted in Russia, will aim to evaluate the efficacy and safety of BCD-281 in comparison with Ocrevus®.
According to Biocad, BCD-281 was previously studied in a Ph I clinical trial, which confirmed its biosimilarity with Ocrevus® across all comparable parameters.
There are a number of ocrelizumab biosimilars currently in development. On 7 August 2025, Sandoz announced that it is streamlining the clinical development programs for its ocrelizumab biosimilar, CYB704, including modifying its Phase 1/3 trial so that it will become a comparative pharmacokinetic trial. In January 2025, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) undergoing Phase 3 trials. Celltrion also has an ocrelizumab biosimilar in development, announcing in August 2023 that the European Medicines Agency (EMA) had partially approved its Phase 3 IND for CT-P53 (ocrelizumab).