BLA

Also known as: Biologics License Application

Biologics License Application — the FDA submission required for biologics (proteins, antibodies, gene therapies).

Definition

A Biologics License Application is the FDA submission required to market a biologic product in the US. Biologics include monoclonal antibodies, recombinant proteins, gene therapies, cell therapies, and vaccines. Unlike NDAs (small molecules), BLAs are governed by the Public Health Service Act.

See also

• NDA — New Drug Application — the FDA submission required to market a new small-molecule drug in the US.
• Biosimilar — A biologic product highly similar to an already-approved reference biologic.

Other regulatory terms

• NDA
• PDUFA date
• Priority review
• Breakthrough Therapy
• Accelerated approval
• Orphan drug