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EU-sourced Avastin®
EU-sourced Avastin® is a VEGF inhibitor (monoclonal antibody) Biologic drug developed by Cipla BioTec Pvt. Ltd.. It is currently in Phase 3 development for Metastatic colorectal cancer, Metastatic non-small cell lung cancer, Metastatic breast cancer.
Avastin (bevacizumab) is a monoclonal antibody that blocks vascular endothelial growth factor (VEGF), preventing tumor blood vessel formation and starving tumors of oxygen and nutrients.
Avastin (bevacizumab) is a monoclonal antibody that blocks vascular endothelial growth factor (VEGF), preventing tumor blood vessel formation and starving tumors of oxygen and nutrients. Used for Metastatic colorectal cancer, Metastatic non-small cell lung cancer, Metastatic breast cancer.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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-sourced Avastin® |
|---|---|
| Sponsor | Cipla BioTec Pvt. Ltd. |
| Drug class | VEGF inhibitor (monoclonal antibody) |
| Target | VEGF (Vascular Endothelial Growth Factor) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Bevacizumab binds to circulating VEGF, a key signaling protein that promotes angiogenesis (new blood vessel growth). By neutralizing VEGF, the drug inhibits the formation of new blood vessels that tumors require to grow and metastasize. This anti-angiogenic mechanism reduces tumor perfusion and can slow or halt tumor progression.
Approved indications
- Metastatic colorectal cancer
- Metastatic non-small cell lung cancer
- Metastatic breast cancer
- Glioblastoma
- Metastatic renal cell carcinoma
- Ovarian cancer
Common side effects
- Hypertension
- Proteinuria
- Hemorrhage
- Thromboembolic events
- Gastrointestinal perforation
- Wound healing complications
- Fatigue
- Diarrhea
Key clinical trials
- Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX04 Versus Avastin® in Healthy Male Subjects (PHASE1)
- Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects (PHASE1)
- Study of Bevacizumab(BAT1706) and Comparators in Healthy Subjects (PHASE1)
- Bioequivalence and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator (PHASE1)
- PK Bioequivalence Single-dose Safety Tolerability Study in Healthy Male Volunteers to Compare CBT124 & Avastin(EU&US) (PHASE1)
- Efficacy-Safety-Immunogenicity Study of CBT124&EU-sourced Avastin® in Stage 4 NSCLC (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:
- EU-sourced Avastin® CI brief — competitive landscape report
- EU-sourced Avastin® updates RSS · CI watch RSS
- Cipla BioTec Pvt. Ltd. portfolio CI
Frequently asked questions about EU-sourced Avastin®
What is EU-sourced Avastin®?
How does EU-sourced Avastin® work?
What is EU-sourced Avastin® used for?
Who makes EU-sourced Avastin®?
What drug class is EU-sourced Avastin® in?
What development phase is EU-sourced Avastin® in?
What are the side effects of EU-sourced Avastin®?
What does EU-sourced Avastin® target?
Related
- Drug class: All VEGF inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting VEGF (Vascular Endothelial Growth Factor)
- Manufacturer: Cipla BioTec Pvt. Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic colorectal cancer
- Indication: Drugs for Metastatic non-small cell lung cancer
- Indication: Drugs for Metastatic breast cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing