Biological medicinal products are promising solutions in the prevention and treatment of various life-threatening chronic diseases and health conditions. Hence, several biopharmaceutical companies are looking forward to developing biological products to cater unmet medical needs. With the US FDA giving special attention towards the approval of Biologics License Applications (BLAs), the challenging part for applicants would be in choosing a 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 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 substantial Regulatory partner with significant experience in Regulatory consulting for biologics and biosimilar products.
Freyr assists sponsors with end-to-end Regulatory support for the BLA submission process, starting from pre-BLA meetings/BPD meetings to post-approval LCM (Life Cycle Management) activities including (but not limited to) supplements/annual reports, LDRs (Lot Distribution Reports), etc. With its well-established infrastructure and expertise, Freyr provides Regulatory support for 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).
- Pre-submission support and strategic support in identifying the optimal Regulatory submission pathway for BLA filing.
- Regulatory support in scheduling the 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 (Refuse to File) challenges.
- Compilation, technical review, finalization, and submission of BLA package for several types of biological/biosimilars 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 expedited review program designations (Fast-Track, Breakthrough Therapy, Accelerated Review, & Priority Review).
- Request for RMAT (Regenerative Medicine Advanced Therapy) 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 for submission of post approval LCM submissions (supplements PAS, CBE 30, CBE/BLA annual reports, etc).