On 15 October 2026, Biocad announced that the Russian Ministry of Health has approved biosimilar ocrelizumab (BCD-281) under the name Ocrelizumab Biocad® for the treatment of adult patients with active relapsing forms of multiple sclerosis and early primary progressive multiple sclerosis.
The registration of Ocrelizumab Biocad® was based on data from a Phase 3 clinical trial in Russia comparing the biosimilar (BCD-281) with the reference product, Roche’s Ocrevus® (ocrelizumab). The commencement of the Phase 3 trial was announced in November 2025, following a Phase 1 clinical trial confirming the biosimilarity of BCD-281 with Ocrevus® across all comparable parameters.
According to Biocad, it is estimated that approximately 150,000 people live with multiple sclerosis in Russia, with approximately 80,000 of these receiving treatment with disease modifying drugs. Biocad expects the release of its biosimilar ocrelizumab to reduce the cost of the therapy by 25%.
Other ocrelizumab biosimilars are in clinical trials sponsored by Sandoz (Phase 3 trial underway, estimated primary completion in November 2026), Amgen (Phase 3 underway, estimated primary completion in 2027), Celltrion (Phase 3 IND for CT-P53 partially approved by the EMA in August 2023, currently recruiting with estimated primary completion in February 2027) and R-Pharm (Phase 1 study commenced April 2025, primary completion in 2026, with estimated completion in November 2027). In January 2026, Samsung Bioepis announced that it had added an ocrelizumab biosimilar to its pipeline and, in July 2026, Teva and Polpharma entered into an exclusive licensing agreement for the commercialisation of Polpharma’s ocrelizumab biosimilar, PB018.