Biologics License Applications Submission - Overview
The Biologics License Application (BLA) serves as a gateway for the development and approval of biological medicinal products, which are promising in the prevention and treatment of various life-threatening chronic diseases and health conditions. Hence, several biopharmaceutical companies are developing biological products to cater to unmet medical needs. With the US FDA giving special attention to the approval of Biologics License Applications (BLAs), the challenge for applicants is choosing the right development strategy for successful BLA filing and subsequent approvals.
With the evolving Regulatory enforcement for advanced therapies such as cellular and gene therapy products and other complex biologics/biosimilars that require extensive evaluation of the quality, safety, and efficacy aspects, Health Authorities (HAs) have started implementing risk-based review procedures. This has triggered complex submission mandates with an extensive list of documents. As a result, there might be chances for missing out on mandatory information in the Biologics License Applications that could lead to an RTF (Refuse-to-File) action by the US FDA. Therefore, BLA sponsors prefer to be associated with a proven Regulatory partner having significant experience in Regulatory consulting for biologics and biosimilar products.
Freyr assists sponsors with end-to-end Regulatory support in the BLA submission process, starting from pre-BLA meetings/BPD meetings to post-approval Lifecycle Management (LCM) activities, including (but not limited to) supplements/annual reports, Lot Distribution Reports (LDRs), etc. With its well-established infrastructure and expertise, Freyr provides Regulatory support in marketing authorizations and the required LCM for various biological products that are approved in both the Regulatory paths (i.e., 351(a) - innovator biologics Regulatory pathway and 351(k) - biosimilar Regulatory pathway).
Biologics License Applications Submission
- Pre-submission and strategic support in identifying the optimal Regulatory submission pathway for BLA filing.
- Regulatory support in scheduling FDA meetings (Type A, B, C, and BPD meetings for biosimilars) and various Agency interactions.
- Regulatory gap analysis (review of developmental data/analytical similarity assessment data), preparation of Regulatory mitigation plans, and Regulatory strategy for both 351(a) BLA submission and 351 (k) BLA submission to avoid RTF challenges.
- The compilation, technical review, finalization, and submission of the Biologics License Application package for several types of biological/biosimilar products (vaccines, recombinant therapeutic protein products, monoclonal antibody products, cellular and gene therapy products, etc.).
- Regulatory consulting on biologics drug development programs and request for the expedited review program designations (Fast-track, Breakthrough Therapy, Accelerated Review, and Priority Review).
- Request for Regenerative Medicine Advanced Therapy (RMAT) designation for cell therapy, therapeutic tissue engineering product, or human cell and tissue products.
- Regulatory strategy for HA queries, Complete Response Letter (CRL) preparation, and on-time submission of responses to the US FDA queries.
- Regulatory support in the filing of post-approval LCM submissions (supplements PAS, CBE 30, CBE/BLA annual reports, etc.).
- Providing BLA Submission Guidance.
- Offering FDA BLA Guidance to sponsors.
- Regulatory advice on BLA Regulatory submission.
- Scheduling BLA Meetings.
- Support in adhering to Biologics License Application Timelines.
