FDA Pathway · Base-Rate Reference
BLA FDA Base Rates
Historical first-cycle approval rates, typical time-to-decision, and AdCom frequency for BLA submissions across 9 therapeutic-area indications. Approximate base rates for framing, not prediction.
What is BLA?
Biologics License Application — CBER or CDER review of biological products (antibodies, vaccines, gene/cell therapies).
BLA base rates by indication
| Indication | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| Oncology | 78% | n~100 | priority 6 months / standard 10 months | sometimes | CAR-T, bispecifics, and checkpoint inhibitors; CMC and comparability issues common CRL drivers. |
| Immunology | 78% | n~80 | standard 10 months | rarely | Mature class with well-understood endpoints; CRLs tend to be CMC or facility-related. |
| Rare Disease / Orphan | 75% | n~60 | priority 6 months | sometimes | Enzyme replacement and gene therapy products; manufacturing inspections a frequent bottleneck. |
| Infectious Disease | 72% | n~50 | priority 6 months | sometimes | Monoclonals and vaccines; EUA-to-BLA conversions common and generally successful. |
| Endocrinology/Metabolic | 70% | n~30 | standard 10 months | sometimes | GLP-1s and similar biologics; safety labeling and CV risk are usual review themes. |
| Other | 70% | n~80 | standard 10 months | sometimes | Includes ophthalmology and dermatology biologics; outcomes generally favorable. |
| Cardiovascular | 65% | n~20 | standard 10 months | usually | PCSK9 class and similar; outcomes data and immunogenicity are key review focal points. |
| Neurology | 60% | n~25 | standard 10 months | usually | Anti-amyloid and ASO programs; AdComs common for contested effect sizes. |
| Psychiatry | 55% | n~10 | standard 10 months | usually | Few biologics in psychiatry; safety and class-effect extrapolation dominate review. |
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 BLA dates?
Our live PDUFA calendar tracks upcoming FDA action dates across all BLA and related submissions with sponsor, ticker, drug, and catalyst context.
View 2026 PDUFA calendar →Related pathways
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