A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows:
The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes:
Applicant information
Product/manufacturing information
Pre-clinical studies
Clinical studies
Labeling[1]
Some biological products are regulated by the Center for Drug Evaluation and Research (CDER) while others are regulated by Center for Biologics Evaluation and Research (CBER).[2]
A BLA is submitted after an investigational new drug has been approved. If the Form 356h is missing information, the FDA will reply within 74 days.[3]
A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number.
After approval, annual reports, reports on adverse events, manufacturing changes, and labeling changes must be submitted.
^"Biologics License Applications (BLA) Process (CBER)". FDA. 2015. Retrieved July 9, 2016.
^"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)
^Group, The FDA. "The Biologics License Application (BLA) Process Explained". www.thefdagroup.com.
and 27 Related for: Biologics license application information
A biologicslicenseapplication (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologicslicenseapplication is a request...
and Drug Administration must respond to a New Drug Application or a BiologicsLicenseApplication. It is part of the regime established by the Prescription...
attracted some controversy in the media. Amgen submitted a biologicslicenseapplication (BLA) for evolocumab to the FDA in August 2014. The FDA approved...
on positive clinical trial results, the company submitted a BiologicsLicenseApplication (BLA) to the FDA for tafasitamab in combination with lenalidomide...
Alliance for Better Access to Developmental Drugs Animal drug Biologicslicenseapplication Drug discovery FDA Fast Track Development Program Good Manufacturing...
States, biologics are licensed through the biologicslicenseapplication (BLA), then submitted to and regulated by the FDA's Center for Biologics Evaluation...
response to a New Drug Application, Amended New Drug Application or BiologicsLicenseApplication, indicating that the application will not be approved...
drug designation. Based on the ZUMA-1 trial, Kite submitted a biologicslicenseapplication for axicabtagene in March 2017, for the treatment of non-Hodgkin...
collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or BiologicsLicenseApplication (BLA) was submitted...
announced acceptance of Spectrum's re-submission of its Rolontis BiologicsLicenseApplication (BLA)to FDA. Aug 6, 2021 Spectrum received a Complete Response...
Global Services, LLC. In November 2016, Janssen submitted a BiologicsLicenseApplication (BLA) to the FDA seeking approval of guselkumab. In July 2017...
Ivory Coast Bla, Mali, a town Blå, a jazz club in Oslo, Norway Biologicslicenseapplication, which is submitted to the U.S. Food and Drug Administration...
of teprotumumab in TED. On 10 July 2019, Horizon submitted a biologicslicenseapplication to the FDA for teprotumumab for the treatment of active thyroid...
2021, the U.S. Food and Drug Administration (FDA) accepted a biologicslicenseapplication for tislelizumab to treat unresectable, recurrent locally advanced...
11 August 2023. Retrieved 30 January 2023. "Janssen Submits BiologicsLicenseApplication to U.S. FDA for Talquetamab for the Treatment of Patients with...
some data previously submitted to the agency as part of the BiologicsLicenseApplication (BLA) package was inaccurate. Specifically, the data manipulation...
application for moxetumomab pasudotox fast track, priority review, and orphan drug designations. The FDA granted the approval of a BiologicsLicense Application...
acute lymphoblastic leukemia (ALL). In October 2014, Amgen's BiologicsLicenseApplication for blinatumomab was granted priority review designation by...
full report on shedding must subsequently be included in the Biologicslicenseapplication. A study of 345 participants aged 5–49 years who received the...
for Leber congenital amaurosis and retinitis pigmentosa. A biologicslicenseapplication was submitted to the US Food and Drug Administration (FDA) in...
undergoes the same approval process but is called a biologicslicenseapplication (BLA). Biological drugs include antibodies, interleukins, and vaccines...
"BiologicsLicenseApplication (BLA) for Zoster Vaccine Recombinant, Adjuvant" (PDF). Office of Vaccines Research and Review, Center for Biologics Evaluation...
Announces U.S. FDA Grants Priority Review for Zolbetuximab BiologicsLicenseApplication". July 6, 2023. Richardson, Jennifer (17 November 2007). "Wholesale...
March 2022. Retrieved 12 March 2022. Beitz J (30 July 2021). "BiologicsLicenseApplication (BLA) for Saphnelo (anifrolumab-fnia) injection" (PDF). Center...
Global Information