PharmaRadar360

PharmaRadar360

NeurologyDrug intelligence

Ocrevus

Ocrelizumab

CD20-directed monoclonal antibody. Developed by Roche. Clinical, regulatory, and source evidence are connected below.

Company
Roche
Target / MOA
CD20 · MS4A1
Aliases
Ocrevus · Ocrevus Zunovo
Signals
21
Clinical trials
16
Approvals
0
Evidence sources
21

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

Early Versus Delayed Start of Ocrevus Zunovo for Relapsing Multiple Sclerosis

N/A · RECRUITING · Oklahoma Medical Research Foundation

clinical trialClinicalTrials.gov

A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)

Phase 2 · ACTIVE_NOT_RECRUITING · Hoffmann-La Roche

clinical trialClinicalTrials.gov

A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)

Phase 2 · NOT_YET_RECRUITING · Hoffmann-La Roche

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Ocrevus · BLA761053 · label version 24, effective May 14, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE OCREVUS is indicated for the treatment of: • Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults • Primary progressive MS, in adults • Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more.

Ocrevus Zunovo · BLA761371 · label version 13, effective Sep 21, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE OCREVUS ZUNOVO is indicated for the treatment of: • Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults • Primary progressive MS, in adults

European Union (EMA)

Ocrevus · EMEA/H/C/004043 · Authorised, authorised Jan 8, 2018 (Commission decision C(2018) 112) · EPAR

Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

BLA761053 · GENENTECH INC · first approved Mar 28, 2017

2 efficacy supplements approved

BLA761371 · GENENTECH INC · first approved Sep 13, 2024

European Union

  • Ocrevus: Authorised since Jan 8, 2018

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

BLA761053 (Purple Book)

No exclusivity date listed.

BLA761371 (Purple Book)

No exclusivity date listed.

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

Boxed warning

The current US labels have no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies · 16 linked records.

N/ARECRUITINGNCT07878923

Early Versus Delayed Start of Ocrevus Zunovo for Relapsing Multiple Sclerosis

Oklahoma Medical Research Foundation · Updated Oct 16, 2026

Phase 2ACTIVE NOT RECRUITINGNCT07074886

A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)

Hoffmann-La Roche · Updated Oct 15, 2026

Phase 2NOT YET RECRUITINGNCT07503340

A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)

Hoffmann-La Roche · Updated Oct 14, 2026

N/ARECRUITINGNCT06780150

A Study to Investigate Effects of Ocrelizumab Treatment on Neurofilament Light Chain (NfL) Levels and Participant Satisfaction in Participants With Multiple Sclerosis (MS)

Hoffmann-La Roche · Updated Oct 13, 2026

Phase 2RECRUITINGNCT07282574

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS)

Hoffmann-La Roche · Updated Oct 7, 2026

Phase 4ACTIVE NOT RECRUITINGNCT07483450

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis

Hoffmann-La Roche · Updated Sep 30, 2026

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Oct 20, 202620EMA Human Medicinesofficial · Latest Oct 16, 20261
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.