Last reviewed · How we verify
Ocrelizumab (EU)
Ocrelizumab (EU) is a CD20-targeting monoclonal antibody Small molecule drug developed by Amgen. It is currently in Phase 3 development for Relapsing forms of multiple sclerosis, Primary progressive multiple sclerosis, Non-Hodgkin's lymphoma.
Ocrelizumab is a monoclonal antibody that targets and depletes CD20-positive B cells.
Ocrelizumab is a monoclonal antibody that targets and depletes CD20-positive B cells. Used for Relapsing forms of multiple sclerosis, Primary progressive multiple sclerosis, Non-Hodgkin's lymphoma.
-
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. -
Big-pharma sponsor
+3.0pp
Amgen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Ocrelizumab (EU) |
|---|---|
| Sponsor | Amgen |
| Drug class | CD20-targeting monoclonal antibody |
| Target | CD20 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By binding to CD20, ocrelizumab induces antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, leading to the depletion of B cells. This mechanism is thought to be beneficial in treating autoimmune diseases such as multiple sclerosis and non-Hodgkin's lymphoma.
Approved indications
- Relapsing forms of multiple sclerosis
- Primary progressive multiple sclerosis
- Non-Hodgkin's lymphoma
Common side effects
- Infusion-related reactions
- Infections
- Neutropenia
Key clinical trials
- Comparison Between ABP 692 and Ocrevus® (Ocrelizumab) (PHASE3)
- Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis (PHASE3)
- A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis (PHASE3)
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:
- Ocrelizumab (EU) CI brief — competitive landscape report
- Ocrelizumab (EU) updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about Ocrelizumab (EU)
What is Ocrelizumab (EU)?
How does Ocrelizumab (EU) work?
What is Ocrelizumab (EU) used for?
Who makes Ocrelizumab (EU)?
What drug class is Ocrelizumab (EU) in?
What development phase is Ocrelizumab (EU) in?
What are the side effects of Ocrelizumab (EU)?
What does Ocrelizumab (EU) target?
Related
- Drug class: All CD20-targeting monoclonal antibody drugs
- Target: All drugs targeting CD20
- Manufacturer: Amgen — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Relapsing forms of multiple sclerosis
- Indication: Drugs for Primary progressive multiple sclerosis
- Indication: Drugs for Non-Hodgkin's lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing