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antibody therapy
antibody therapy is a Biologic drug developed by St. Vincent Medical Center - Los Angeles. It is currently in Phase 1 development. Also known as: passive antibody therapy.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | antibody therapy |
|---|---|
| Also known as | passive antibody therapy |
| Sponsor | St. Vincent Medical Center - Los Angeles |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- antibody therapy CI brief — competitive landscape report
- antibody therapy updates RSS · CI watch RSS
- St. Vincent Medical Center - Los Angeles portfolio CI
Frequently asked questions about antibody therapy
What is antibody therapy?
Who makes antibody therapy?
Is antibody therapy also known as anything else?
What development phase is antibody therapy in?
Related
- Manufacturer: St. Vincent Medical Center - Los Angeles — full pipeline
- Also known as: passive antibody therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing