BLA: Biologics License Application

If any organization wants to sell a biologic product in the United States, it must submit a BLA to the Food and Drug Administration (FDA). Specifically, a successful BLA grants permission for an organization to distribute a biologic product across state lines.

A biologic product includes:

• Vaccines
• Blood and blood components
• Allergenics
• Somatic cells
• Gene therapy
• Tissues
• Recombinant therapeutic proteins

Any company or entity that wants to market a biological product in the U.S. must submit a BLA to the FDA. It is mandatory for regulatory approval under the Public Health Service (PHS) Act before commercial distribution.

Organizations interested in obtaining a biologics license must fill and submit Form FDA 356h to the Center for Biologics Evaluation and Research (CBER).

The submission process also encompasses:

• Data compilation. Gathering preclinical, clinical, manufacturing, and labeling information
• The FDA review process. The FDA evaluates safety, efficacy, and manufacturing compliance.
• Facility inspection. The FDA may inspect manufacturing sites for compliance with Good Manufacturing Practices (GMP) compliance
• Approval. The FDA either approves, requests more information, or rejects the application

While a biologics license does not require renewal, organizations must comply with regulatory requirements to maintain its validity. These include:

• Annual reports. Biologics license holders must submit yearly reports detailing manufacturing, safety, and quality updates
• Adverse event reporting. Companies must track and report adverse events, following pharmacovigilance regulations
• Manufacturing and FDA inspections. Facilities must comply with GMP regulations
• Labeling and lot release. Updates to safety labeling must be submitted for FDA review. Some biologics require pre-distribution lot release, ensuring each batch meets quality, potency, and stability requirements before public distribution

A biologics license several benefits to organizations. Some key advantages include the following.

Earning a biologics license may pose several challenges to employees and organizations. They include the following.

Here are a few tips for preparing a BLA:

• Read and study the resources on the FDA’s website
• Read the instruction sheet for Form FDA 356h
• Conduct well-designed clinical trials that demonstrate safety, efficacy, and consistency
• Ensure compliance with GMP standards, detailing production processes, quality controls, and stability studies for regulatory approval
• Schedule pre-BLA meetings and regulatory consultations to address potential concerns

For more information and guidance on BLA submission, you can refer to the following resources:

FDA. The Food and Drug Administration offers a wealth of resources regarding BLA submission. Its website should be the first stop for any organization seeking to enter the biologics market.

AG5 stores all certifications in the cloud, providing all authorized personnel with access to the right version of approved certifications. This helps you easily keep track of all data and documentation related to biologics licenses across your organization.

Using AG5’s skills management software, you can monitor the status of any type of certification that is relevant to your workforce, leveraging intuitive dashboards that provide you with a clear understanding of exactly what is needed to keep your employees skilled and safe.

• FDA