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Subgam
Subgam is a Biologic drug developed by Bio Products Laboratory. It is currently in Phase 3 development. Also known as: Subgam-VF.
Subgam is a human normal immunoglobulin solution used to treat Primary Immune Deficiency Disorders, including conditions such as Common Variable Immunodeficiency, X-linked Agammaglobulinaemia, and Hyperimmunoglobulin M Syndrome. It is administered as part of a treatment for Primary Antibody Deficiency, as indicated in clinical trials.
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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).
| 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 | Subgam |
|---|---|
| Also known as | Subgam-VF |
| Sponsor | Bio Products Laboratory |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases (PHASE3)
- A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam® (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:
- Subgam CI brief — competitive landscape report
- Subgam updates RSS · CI watch RSS
- Bio Products Laboratory portfolio CI
Frequently asked questions about Subgam
What is Subgam?
Who makes Subgam?
Is Subgam also known as anything else?
What development phase is Subgam in?
Related
- Manufacturer: Bio Products Laboratory — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Subgam-VF
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing