Definition
BLA (Biologics License Application) is the regulatory submission required for FDA approval to manufacture and market biologic products in the United States. Biologics are complex molecules derived from living organisms, including vaccines, therapeutic proteins, monoclonal antibodies, and cell therapies.
How BLA Works
BLAs are regulated under Section 351 of the Public Health Service Act. The application must demonstrate the biologic is safe, pure, and potent. Manufacturing facility approval is integral to the BLA.
Key Requirements
- Complete characterization of the biologic product
- Clinical safety and efficacy data
- Chemistry, manufacturing, and controls for biologics
- Facility inspection and compliance documentation
- Proposed labeling including biosimilar considerations
- Environmental impact assessment
BLA vs NDA
| Aspect | BLA | NDA |
|---|---|---|
| Product Type | Biologics (proteins, mAbs, vaccines) | Small molecules |
| Regulatory Act | PHS Act Section 351 | FD&C Act Section 505 |
| Manufacturing | Integral to license | Separate from approval |
| Exclusivity | 12 years (reference product) | 5 years (NCE) |
| Review Center | CBER or CDER | CDER |
Recent BLA Approvals
| Drug | Company | Approval Date | Type |
|---|---|---|---|
| Lecanemab (Leqembi) | Eisai/Biogen | Jul 2023 | Monoclonal antibody |
| Etrasimod (Velsipity) | Pfizer | Oct 2023 | S1P receptor modulator |
| Talquetamab (Talvey) | J&J | Aug 2023 | Bispecific antibody |
Why BD Teams Track BLA
For business development professionals, BLA submissions represent high-value assets:
- Deal Implication: Biologics command premium valuations; BLA-stage assets often attract major deals
- Due Diligence Focus: Manufacturing capability and CMC complexity are critical evaluation factors
- Opportunity Signal: 12-year exclusivity for reference biologics provides extended commercial runway