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Betaseron (INTERFERON BETA-1B)
Betaseron works by binding to the interferon alpha/beta receptor, which helps to reduce inflammation and slow disease progression in multiple sclerosis.
Betaseron (Interferon Beta-1B) is a recombinant form of interferon beta-1b, a small molecule drug developed by Bayer Healthcare Pharmaceuticals. It targets the interferon alpha/beta receptor to modulate the immune system's response in patients with relapsing-remitting multiple sclerosis. Betaseron was FDA-approved in 1993 and remains a patented product. Key safety considerations include injection site reactions, flu-like symptoms, and potential liver enzyme elevations. As a recombinant protein, Betaseron's commercial status is not affected by generic manufacturers.
At a glance
| Generic name | INTERFERON BETA-1B |
|---|---|
| Sponsor | Bayer Healthcare Pharms |
| Drug class | Interferon beta |
| Target | Interferon alpha/beta receptor |
| Modality | Recombinant protein |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1993 |
Mechanism of action
Think of Betaseron like a messenger that helps calm down the immune system's attack on the protective covering of nerve fibers in the brain and spinal cord. By reducing inflammation, Betaseron helps slow the progression of multiple sclerosis and reduce the frequency of relapses. This can help patients maintain their ability to function and manage their symptoms.
Approved indications
- Relapsing remitting multiple sclerosis
Common side effects
- Lymphocytes count decreased (<1500/mm3)
- Absolute neutrophil count decreased (<1500/mm3)
- White blood cell count decreased (<3000/mm3)
- Lymphadenopathy
- Headache
- Insomnia
- Incoordination
- Hypertension
- Dyspnea
- Abdominal pain
- Alanine aminotransferase increased (SGPT > 5 times baseline)
- Aspartate aminotransferase increased (SGOT > 5 times baseline)
Key clinical trials
- An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden
- Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial (NA)
- Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (PHASE4)
- US PROmyBETAapp2.0: A Study to Learn More About the Medication Usage and Patient Reported Outcomes Via the myBETAapp in Medical Care of Patients With Multiple Sclerosis Treated With BETASERON Using BETACONNECT Autoinjector
- Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
- Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS) (PHASE2)
- Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation (PHASE2,PHASE3)
- Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI (PHASE4)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Betaseron CI brief — competitive landscape report
- Betaseron updates RSS · CI watch RSS
- Bayer Healthcare Pharms portfolio CI