Sandoz’s Biosimilar Trial: A Potential Game-Changer for Multiple Sclerosis Treatment

Sandoz Group Ltd ((SDZXF)) announced an update on their ongoing clinical study.

Study Overview: Sandoz Group Ltd is conducting a clinical trial titled A Randomized, Double-blind, Parallel-group Study to Compare the Pharmacokinetics, Efficacy, Pharmacodynamics, Safety, and Immunogenicity of CYB704 (Proposed Ocrelizumab Biosimilar) and Ocrevus® in Participants With Relapsing Multiple Sclerosis (RMS). The study aims to determine if CYB704, a proposed biosimilar to Ocrevus, matches the original in distribution, efficacy, and safety, which is significant for expanding treatment options for multiple sclerosis.

Intervention/Treatment: The trial tests CYB704, an experimental biosimilar to Ocrevus, against the original Ocrevus (both EU and US versions). All are administered via intravenous infusion, with the goal of establishing CYB704 as a viable alternative for treating relapsing multiple sclerosis.

Study Design: This Phase 3 study is interventional and randomized, with a parallel assignment model. It employs quadruple masking, meaning that the participant, care provider, investigator, and outcomes assessor are all blinded. The primary purpose is treatment-focused, aiming to validate the biosimilar’s effectiveness and safety.

Study Timeline: The study began on February 19, 2025, with the latest update submitted on October 13, 2025. These dates are crucial as they indicate the study’s current recruiting status and ongoing progress towards completion.

Market Implications: If successful, this study could significantly impact Sandoz’s market position by introducing a cost-effective alternative to Ocrevus, potentially boosting its stock performance. The biosimilar market is competitive, and a positive outcome could enhance investor confidence and influence industry dynamics.

The study is currently ongoing, with further details available on the ClinicalTrials portal.