Last reviewed 2026-05-14 · How we verify

EU-Ocrevus

Celltrion · Phase 3 active Biologic

EU-Ocrevus is a CD20-targeting monoclonal antibody Biologic drug developed by Celltrion. It is currently in Phase 3 development for Multiple sclerosis (relapsing and progressive forms), Granulomatosis with polyangiitis (GPA), Microscopic polyangiitis (MPA). Also known as: Ocrelizumab.

EU-Ocrevus is a monoclonal antibody that binds to CD20 on B cells, leading to their depletion and reduction of autoimmune activity.

EU-Ocrevus is a monoclonal antibody that binds to CD20 on B cells, leading to their depletion and reduction of autoimmune activity. Used for Multiple sclerosis (relapsing and progressive forms), Granulomatosis with polyangiitis (GPA), Microscopic polyangiitis (MPA).

Likelihood of approval

59.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	EU-Ocrevus
Also known as	Ocrelizumab
Sponsor	Celltrion
Drug class	CD20-targeting monoclonal antibody
Target	CD20
Modality	Biologic
Therapeutic area	Immunology
Phase	Phase 3

Mechanism of action

EU-Ocrevus targets CD20, a surface antigen expressed on B lymphocytes. By binding to CD20, the antibody triggers B cell destruction through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), thereby reducing the pathogenic B cell population involved in autoimmune diseases. This mechanism reduces inflammation and autoimmune-mediated tissue damage.

Approved indications

Multiple sclerosis (relapsing and progressive forms)
Granulomatosis with polyangiitis (GPA)
Microscopic polyangiitis (MPA)

Common side effects

Infusion-related reactions
Upper respiratory tract infections
Headache
Fatigue
Nasopharyngitis
Immunosuppression/infections

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

EU-Ocrevus CI brief — competitive landscape report
EU-Ocrevus updates RSS · CI watch RSS
Celltrion portfolio CI

Frequently asked questions about EU-Ocrevus

What is EU-Ocrevus?

EU-Ocrevus is a CD20-targeting monoclonal antibody drug developed by Celltrion, indicated for Multiple sclerosis (relapsing and progressive forms), Granulomatosis with polyangiitis (GPA), Microscopic polyangiitis (MPA).

How does EU-Ocrevus work?

EU-Ocrevus is a monoclonal antibody that binds to CD20 on B cells, leading to their depletion and reduction of autoimmune activity.

What is EU-Ocrevus used for?

EU-Ocrevus is indicated for Multiple sclerosis (relapsing and progressive forms), Granulomatosis with polyangiitis (GPA), Microscopic polyangiitis (MPA).

Who makes EU-Ocrevus?

EU-Ocrevus is developed by Celltrion (see full Celltrion pipeline at /company/celltrion).

Is EU-Ocrevus also known as anything else?

EU-Ocrevus is also known as Ocrelizumab.

What drug class is EU-Ocrevus in?

EU-Ocrevus belongs to the CD20-targeting monoclonal antibody class. See all CD20-targeting monoclonal antibody drugs at /class/cd20-targeting-monoclonal-antibody.

What development phase is EU-Ocrevus in?

EU-Ocrevus is in Phase 3.

What are the side effects of EU-Ocrevus?

Common side effects of EU-Ocrevus include Infusion-related reactions, Upper respiratory tract infections, Headache, Fatigue, Nasopharyngitis, Immunosuppression/infections.

What does EU-Ocrevus target?

EU-Ocrevus targets CD20 and is a CD20-targeting monoclonal antibody.

Drug class: All CD20-targeting monoclonal antibody drugs
Target: All drugs targeting CD20
Manufacturer: Celltrion — full pipeline
Therapeutic area: All drugs in Immunology
Indication: Drugs for Multiple sclerosis (relapsing and progressive forms)
Indication: Drugs for Granulomatosis with polyangiitis (GPA)
Indication: Drugs for Microscopic polyangiitis (MPA)
Also known as: Ocrelizumab

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing