OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq) · Roche
OCREVUS ZUNOVO is a combination of ocrelizumab and hyaluronidase-ocsq indicated for the treatment of multiple sclerosis in adult patients. It is approved for relapsing forms of the disease, which include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The medication is also indicated for the treatment of primary progressive multiple sclerosis. This therapeutic provides a CD20-directed treatment option for various stages of the condition.
How OCREVUS ZUNOVO Works
Ocrelizumab is a cytolytic antibody that targets CD20, an antigen found on the surface of pre-B and mature B lymphocytes. Upon binding, it induces B cell depletion through antibody-dependent cellular cytolysis and complement-mediated lysis. The hyaluronidase component functions by depolymerizing hyaluronan to transiently increase the permeability of the subcutaneous tissue at the injection site. This local effect is reversible, with tissue permeability typically restored within 24 to 48 hours.
Details
- Status
- Prescription
- First Approved
- 2024-09-13
- Revenue
- $2.3B (Q3-2026) converted from CHF 1,847m
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OCREVUS ZUNOVO Approval History
What OCREVUS ZUNOVO Treats
1 indicationsOCREVUS ZUNOVO is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
OCREVUS ZUNOVO Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in OCREVUS ZUNOVO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OCREVUS ZUNOVO treats. First-in-class if their pivotal trials read out positive.
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Roche's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OCREVUS ZUNOVO FDA Label Details
Indications & Usage
FDA Label (PDF)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 OCREVUS ZUNOVO is a CD20-directed cytolytic antibody 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
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Deep insights for OCREVUS ZUNOVO
Revenue Insights
- • Q3-2026: $2.3B (converted from CHF 1,847m)
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.