BLA

Medical abbreviation · Pharmacy

BLA
Stands forBiologics License Application
CategoriesMedical

BLA stands for Biologics License Application, a pharmacy abbreviation.

Application to the FDA for permission to market a biological product, such as a monoclonal antibody, vaccine, blood product or gene therapy, under the Public Health Service Act. It is the counterpart of the NDA for chemically synthesized drugs.

Example: The company submitted a BLA for its monoclonal antibody after two positive phase 3 trials.

Usage notes

Biosimilars use an abbreviated pathway created by the Biologics Price Competition and Innovation Act of 2010, filed under section 351(k). Most BLAs are reviewed by the FDA's Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research, depending on product type.

More pharmacy abbreviations

  • APhA – American Pharmacists Association
  • API – Active pharmaceutical ingredient
  • aq – Aqueous
  • ARCOS – Automation of Reports and Consolidated Orders System
  • ASHP – American Society of Health-System Pharmacists
  • AWP – Average wholesale price
  • BOP – Board of pharmacy
  • BP – British Pharmacopoeia
  • BPMH – Best possible medication history
  • BTC – Behind the counter
  • BUD – Beyond-use date
  • C-I – Schedule I controlled substance

See all 134 pharmacy abbreviations →

Edited by the AbbreviationList.com team. Spotted an error or a missing meaning? Contact us.

This entry is for general education and is not medical advice. Abbreviation use varies between institutions; always confirm in context.