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Biologics License Application (BLA)

A Biologics License Application (BLA) is the route through which biologics are licensed in the United States[1]. A BLA is submitted after the investigational new drug (IND) phase, once the clinical investigations are completed[2].

A biologic is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources[3]. Examples include vaccines, gene therapies and monoclonal antibodies[3]. Some biological products are regulated by the Center for Drug Evaluation and Research (CDER) while others are regulated by the Center for Biologics Evaluation and Research (CBER)[4]. If the Form 356h is missing information, the FDA will reply within 74 days[2].

Approval may require several years of clinical trials, including trials with human volunteers[1]. The manufacturing process must satisfy the FDA's Good Manufacturing Practices[1]. Even after the drug is released, it will still be monitored for performance and safety risks[1].

The PDUFA date is the colloquial name for the date by which the FDA must respond to a New Drug Application or a Biologics License Application[5]. Under the PDUFA regime, a fee is levied on these applications upon filing[6]. In return, the FDA strives to complete review of applications within 10 months for most applications and 6 months for priority reviews[7]. The FDA may extend the PDUFA date in certain circumstances[8]. These include a 'major amendment', for example where data submitted to a final study report is updated or data inadvertently omitted is supplied[9].

Why it matters to investors

The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected[5]. The FDA may extend the PDUFA date in certain circumstances[8].

Related: Investigational New Drug (IND), New Drug Application (NDA), Priority review

Sources

  1. Kingham R, Klasa G, Carver K (2014). Key Regulatory Guidelines for the Development of Biologics in the United States and Europe (PDF) . John Wiley & Sons, Inc. pp. 75– 88. Archived from the original (PDF) on 2 August 2021 . Retrieved 11 April 2018 . web.archive.org (via Wikipedia: Biopharmaceutical)
  2. Group, The FDA. "The Biologics License Application (BLA) Process Explained" . www.thefdagroup.com . {{ cite web }} : | last= has generic name ( help ) thefdagroup.com (via Wikipedia: Biologics license application)
  3. Walsh, Gary (2018). "Biopharmaceutical benchmarks 2018" . Nature Biotechnology . 36 (12): 1136– 1145. doi : 10.1038/nbt.4305 . ISSN 1087-0156 . PMID 30520869 . doi.org; Ryan, Michael P.; Walsh, Gary (2012). "Veterinary-based biopharmaceuticals" . Trends in Biotechnology . 30 (12): 615– 620. doi : 10.1016/j.tibtech.2012.08.005 . PMID 22995556 . linkinghub.elsevier.com (via Wikipedia: Biopharmaceutical)
  4. "Archived copy" (PDF) . Food and Drug Administration . Archived from the original (PDF) on February 3, 2017 . Retrieved January 27, 2017 . {{ cite web }} : CS1 maint: archived copy as title ( link ) web.archive.org (via Wikipedia: Biologics license application)
  5. Speights, Keith (2016-07-07). "What Is a PDUFA Date?" . The Motley Fool . Retrieved 2021-06-30 . fool.com (via Wikipedia: PDUFA date)
  6. "Prescription Drug User Fee Rates for Fiscal Year 2021" . Federal Register . 2020-08-03 . Retrieved 2021-06-30 . federalregister.gov (via Wikipedia: PDUFA date)
  7. "GAO Analysis Says FDA is Meeting PDUFA Commitments" . FDA Law Blog . 2020-04-09 . Retrieved 2021-06-30 . thefdalawblog.com (via Wikipedia: PDUFA date)
  8. Center for Drug Evaluation and Research, Office of New Drugs. "Manual of Policies and Procedures (MAPP) 6010.8 Rev. 1: NDAs and BLAs: Communication to Applicants of Planned Review Timelines" . FDA, Center for Drug Evaluation and Research . Archived from the original on September 10, 2019 . Retrieved 2021-06-30 . web.archive.org (via Wikipedia: PDUFA date)
  9. "When Does FDA Extend a PDUFA Date? | Eye on FDA" . eyeonfda.com . Retrieved 2021-06-30 . eyeonfda.com (via Wikipedia: PDUFA date)

Checked 8 October 2026. How we check sources