On 8 May 2026, Genentech announced that Ocrevus® (ocrelizumab), as IV infusion, has been approved by the FDA for the treatment of relapsing-remitting multiple sclerosis (RRMS) in paediatric patients aged 10 years and older who weigh at least 25 kg.
Ocrevus® was first approved in the US in 2017 for both relapsing and primary progressive forms of multiple sclerosis in adults.
Ocrelizumab biosimilars are in clinical trials sponsored by Amgen (Phase III underway), Biocad (Phase III, enrolment commenced November 2025), Sandoz (comparative pharmacokinetic trial underway) and Celltrion (Phase III IND for CT-P53 partially approved by the EMA in August 2023). In September 2025, Polpharma and MS Pharma entered a licensing agreement for the commercialisation of an ocrelizumab biosimilar in the MENA region. In January 2026, Samsung Bioepis announced that it had added an ocrelizumab biosimilar to its pipeline.