FDA Pathway · Base-Rate Reference
sBLA FDA Base Rates
Historical first-cycle approval rates, typical time-to-decision, and AdCom frequency for sBLA submissions across 9 therapeutic-area indications. Approximate base rates for framing, not prediction.
What is sBLA?
Supplemental BLA — expansions or modifications to an already-approved biologic (new indication, new population, manufacturing change).
sBLA base rates by indication
| Indication | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| Oncology | 88% | n~300 | priority 6 months | rarely | Label expansions for approved checkpoint inhibitors, ADCs, and targeted therapies; first-cycle approval common. |
| Immunology | 88% | n~120 | standard 10 months | rarely | Class-effect extrapolation supports high approval rates for new indications. |
| Rare Disease / Orphan | 85% | n~80 | priority 6 months | rarely | Pediatric and adjacent-indication expansions; high approval rates with concise supplements. |
| Infectious Disease | 85% | n~50 | priority 6 months | rarely | Pediatric indications, new pathogens, and combination claims typically approved first cycle. |
| Endocrinology/Metabolic | 82% | n~40 | standard 10 months | rarely | Weight management and CV risk expansions for GLP-1 class; strong first-cycle record. |
| Other | 82% | n~150 | standard 10 months | rarely | Aggregated across therapeutic areas; sBLA success rates consistently outpace original BLAs. |
| Cardiovascular | 80% | n~30 | standard 10 months | sometimes | Expansion to new outcomes claims (MACE, HF); AdComs possible when new populations are controversial. |
| Neurology | 75% | n~25 | standard 10 months | sometimes | Pediatric and symptomatic-to-modifying expansions; evidence bar remains high. |
| Psychiatry | 75% | n~15 | standard 10 months | sometimes | Expansions into adjacent indications generally successful when safety maintained. |
Base rates drawn from published FDA approval analyses covering roughly 2008-2022. Cross-check against recent CDER/CBER reports for specific assets.
Run your specific pathway + indication combo
The full calculator lets you layer on designations (Breakthrough, Fast Track, Priority Review) and see how they shift base rate, time-to-decision, and AdCom likelihood.
Open the calculator →Who has upcoming sBLA dates?
Our live PDUFA calendar tracks upcoming FDA action dates across all sBLA and related submissions with sponsor, ticker, drug, and catalyst context.
View 2026 PDUFA calendar →Related pathways
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