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alb-interferon alfa 2b
alb-interferon alfa 2b is a Small molecule drug developed by Novartis. It is currently in Phase 2 development. Also known as: ABF656.
Alb-interferon alfa 2b, also known as Albuferon, has been studied in clinical trials for the treatment of chronic hepatitis C and hepatitis B virus. It has been used in combination with ribavirin in a Phase 2b study for the treatment of chronic hepatitis C genotype 1 in interferon-naive subjects.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Novartis 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | alb-interferon alfa 2b |
|---|---|
| Also known as | ABF656 |
| Sponsor | Novartis |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient (PHASE1, PHASE2)
- Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients (PHASE1)
- An Open Label Non-Randomized Dose Escalating Trial to Assess Safety and Tolerability of Alb-Interferon Alfa 2b Every Two Weeks With Ribavirin Among HIV/HCV Coinfected Individuals (PHASE1)
- Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Chinese Healthy Volunteers (PHASE1)
- Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients (PHASE2)
- A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1 (PHASE2)
- Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared With Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients (PHASE3)
- Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3 (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:
- alb-interferon alfa 2b CI brief — competitive landscape report
- alb-interferon alfa 2b updates RSS · CI watch RSS
- Novartis portfolio CI
Frequently asked questions about alb-interferon alfa 2b
What is alb-interferon alfa 2b?
Who makes alb-interferon alfa 2b?
Is alb-interferon alfa 2b also known as anything else?
What development phase is alb-interferon alfa 2b in?
Related
- Manufacturer: Novartis — full pipeline
- Also known as: ABF656
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing