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US licenced Avastin®
US licenced Avastin® is a Small molecule drug developed by mAbxience Research S.L.. It is currently in Phase 1 development. Also known as: Bevacizumab (United States), Bevacizumab (US sourced).
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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 | US licenced Avastin® |
|---|---|
| Also known as | Bevacizumab (United States), Bevacizumab (US sourced) |
| Sponsor | mAbxience Research S.L. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Nasopharyngitis
- Headache
- Back pain
- Oropharyngeal pain
- Upper respiratory tract infection
- Cough
- Rhinitis
- Nausea
- Blood Creatine Phosphokinase Increased
- Diarrhoea
- Pulpitis dental
- Myalgia
Key clinical trials
- A Study Comparing the Pharmacokinetic Similarity of MB02-SP, MB02-DM and US Licensed-Avastin®. (PHASE1)
- Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers (PHASE1)
- A Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers (PHASE1)
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:
- US licenced Avastin® CI brief — competitive landscape report
- US licenced Avastin® updates RSS · CI watch RSS
- mAbxience Research S.L. portfolio CI
Frequently asked questions about US licenced Avastin®
What is US licenced Avastin®?
Who makes US licenced Avastin®?
Is US licenced Avastin® also known as anything else?
What development phase is US licenced Avastin® in?
What are the side effects of US licenced Avastin®?
Related
- Manufacturer: mAbxience Research S.L. — full pipeline
- Also known as: Bevacizumab (United States), Bevacizumab (US sourced)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing