CT-P53 (ocrelizumab biosimilar) / Celltrion - LARVOL DELTA

A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis (clinicaltrials.gov) - P3 | N=512 | Recruiting | Sponsor: Celltrion | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Multiple Sclerosis

Celltrion wins phase 3 IND approval for Ocrevus biosimilar in US - "South Korea's biopharmaceutical company Celltrion Inc. announced that it received on Thursday approval from the US Food and Drug Administration (FDA) for the phase 3 investigational new drug (IND) application of its biosimilar CT-P53 for Ocrevus (ingredient: ocrelizumab), a treatment for multiple sclerosis...The company plans to conduct comparative studies on efficacy, pharmacokinetics and safety between CT-P53 and the original drug Ocrevus in a total of 512 relapsing-remitting multiple sclerosis patients....The company aims to expand its biosimilar product portfolio to 11 items by 2025."

IND • CNS Disorders • Immunology • Multiple Sclerosis

A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis (clinicaltrials.gov) - P3 | N=512 | Not yet recruiting | Sponsor: Celltrion

New P3 trial • CNS Disorders • Multiple Sclerosis

Celltrion submits phase 3 plan for multiple sclerosis biosimilar to FDA (Korea Biomedical Review) - "Celltrion said on Monday that it submitted a phase 3 investigational new drug (IND) plan to the U.S. Food and Drug Administration (FDA) for CT-P53, a biosimilar of the multiple sclerosis drug, Ocrevus (ingredient: ocrelizumab)....The phase 3 global clinical trial of CT-P53 will be a comparative study on the effectiveness, pharmacokinetics, and safety between CT-P53 and Ocrevus on 512 patients with recurrent palliative multiple sclerosis."

New P3 trial • Immunology • Multiple Sclerosis