What is a Biologics License Application?

What Is a Biologics License Application (BLA)?

The Biologics License Application (BLA) is a request to the US FDA for permission to introduce a biologic product to the market. These products are derived from living material and include therapeutics proteins, monoclonal antibodies, vaccines, etc, and usually demonstrate a complex structure which can be difficult to characterize. The Centre for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) regulate biological products depending on its classification.

The Biologics License Application (BLA) is a request to the US FDA for permission to introduce a biologic product to the market. These products are derived from living material and include therapeutics proteins, monoclonal antibodies, vaccines, etc, and usually demonstrate a complex structure which can be difficult to characterize. The Centre for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) regulate biological products depending on its classification.

The Biologics License Application (BLA) Process:

Application Preparation: Those involved in the manufacturing of biologics can apply for a BLA. Before submitting the application, applicants typically need to schedule a meeting with the FDA to discuss their plans. This may also include arranging a bioresearch monitoring inspection and reviewing the timing of submission based on advisory committee schedules and needs.

Submission of the FDA 356h form: Applicants must submit a Form FDA 356h to the FDA and should include information on preclinical and clinical data on the product, draft labelling, details on manufacturing, chemistry, and controls, and facility descriptions.

FDA Review:Upon receiving the BLA, the FDA conducts an initial review to determine if the application is complete. This includes assessing standard operating procedures and validation data. After this initial review, a filing letter may be issued.

Filing Letter and Review Committee: If the FDA issues a filing letter, the advisory committee conducts a comprehensive review of the BLA. This scientific review involves personnel from various disciplines. The FDA may also request a pre-licensing inspection to ensure regulatory compliance. Discipline review letters may be issued as reviews by specific disciplines are completed. The review committee will meet to identify any issues, agreements, or commitments.

Outcome: Depending on the findings of the review, several outcomes are possible. These include issuing an RTF, requesting additional information, or determining that the product is not ready for approval. If the FDA approves the BLA, they will issue an approval letter, allowing the manufacturer to distribute the product. The approval letter may also outline any agreements and commitments.

DDReg’s Capabilities

DDReg has supported its customers for successful BLA filings for a variety of biological products. Its BLA services include:

Support in developing a robust regulatory strategy for BLA filing to reduce the chances of ‘RTF’

Comprehensive gap analysis and tailored remediation plans for biologics under the 351(a) and 351(k) BLA submission pathways

End-to-end support in compilation, review, and submission of BLA filings for a biological and biosimilar products

Strategic advisory and consulting for expedited review processes include fast-track, accelerated, and priority review.

Preparing for meetings with the FDA (i.e., BPD for biosimilars, Type A, B, C)