A Biologics License Application (BLA) is required formal documentation by the Food and Drug Administration (FDA) in order for sponsors, pharmaceutical companies, and other pharmacology-adjacent companies to receive approval to market a new drug within the United States.
The Biologics License Application is regulated under 21 CFR 600 – 680, and in detail explains the regulations and permissions associated with “a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.”
With the FDA’s approval of a Biologics License Application, the manufacturing party will be able to legally market and distribute their product across state lines.
What is a Biologic Product?
A biologic product is “products that include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.” These drugs differ from conventional drugs in the aspect that they are structurally complex mixtures that are not clearly defined or characterized. Most drugs that are chemically synthesized are the opposite whereas their structures are known.
Biologic products and the end result drugs are derived from a variety of natural sources including humans, animals, and microorganisms. Biologic products are typically cutting-edge and pave the way for potential effective treatment for a variety of medical conditions that lack a care option.
What Needs to Be Included in a Biologics License Application?
The process associated with completing a Biologics License Application requires expert knowledge and insight regarding FDA drug application submissions. The start of the BLA process begins with Form FDA 365h. This three-page application is submitted to the Center for Biologics Evaluation and Research (CBER) — a branch within the FDA.
In Form FDA 365h, the applying party is tasked with filling out and providing all necessary documentation on related drug information surrounding:
- Applicant information
- Product/Manufacturing information
- Pre-clinical studies
- Clinical studies
- Labeling
In the submitted information, the BLA should showcase many of the same requirements as a New Drug Application.
More detailed explanations are needed to illustrate:
- The drug product is safe and effective for use in patients with the specified disease
- The drug product’s risks of use are outweighed by the benefits it provides
- The proposed labeling and package inserts for commercialization provide all necessary information for the end-user
- The drug is manufactured in a way that preserves its quality and properties through continuous batches
But, as biological products are created from living material, a BLA must show evidence that the final product does not contain extraneous material. As biological products are typically complicated in nature, a pre-license inspection of the manufacturing facility is generally required before a BLA is approved.
Who Can Submit The Biologics License Application?
A BLA can be submitted by any legal person or entity who is engaged in the manufacturing or application for license process, and who takes responsibility for product compliance and established standards.
Biologics License Application Timeline
The FDA accepts both paper and electronic applications, but since the implementation of the Electronic Common Technical Document (eCTD), submission via this method is generally considered best practice.
The typical review timeline and approval process of a BLA follows these general guidelines:
- The sponsor must notify FDA within 1 year of the NDA/BLA submission and can request a pre-NDA/BLA meeting with their review division to address any questions and get direct feedback
- From submission, FDA has 60 days to first validate the dossier, and provide a filing letter to communicate their decision to continue with the review
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Once Validated, FDA has 10 months to perform their standard review of the application’s contents
- If a sponsor qualifies for priority review, this time is cut down to 6 months
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Following their review, FDA will either send an approval letter or a complete response letter back to the sponsor
- A complete response letter provides a summary of the deficiencies which will need to be addressed via amendments to the NDA
- The approval letter authorizes the sponsor the manufacture and sell their product
Biologics License Application Guidance
Due to the intricacies and complexity of biologics, BLAs are often not as straightforward as some of the other FDA product applications. BioPharma Global offers a variety of benefits for those parties needing to submit and navigate the biologics drug process.
With expertise on all stages and aspects of the BLA, our team of industry professionals is able to help on:
- Regulatory strategy
- Gap analysis
- Document authoring
- eCTD publishing and electronic submission
- Pre-NDA/BLA meeting assistance
- FDA communications
If your organization is needing to navigate the BLA submission process or has struggled to do so in the past, get in contact with us today. BioPharma Global has a proven track record of helping businesses achieve regulatory compliance and meet strict guideline standards.
