Regulatory Strategy and Insights - Overview
Health Authorities (HAs) have begun implementing risk-based review procedures for the approval of Biologics License Applications (BLAs) due to evolving Regulatory enforcement for advanced therapies like cellular and gene therapy products, as well as other complex biologics/biosimilars that necessitate a thorough evaluation of drug product quality, safety, and efficacy aspects. As a result, there might be chances of missing out on mandatory information in the Biologics License Applications that could lead to a Refuse-to-File (RTF) action by the United States Food and Drug Administration (US FDA). Therefore, BLA sponsors prefer to be associated with a proven Regulatory partner with significant experience in Regulatory consulting for biologics and biosimilars.
Freyr assists sponsors with end-to-end Regulatory support in the BLA submission process, from pre-BLA meetings/BPD meetings to post-approval Lifecycle Management (LCM) activities. Additionally, our experienced team provides Regulatory support for marketing authorizations and relevant LCM for various biological products approved in both the Regulatory paths (i.e., 351(a) Innovator Biologics Regulatory pathway and 351(k) Biosimilar Regulatory pathway).
Biologics License Application (BLA) - Expertise
- Pre-submission and strategic support in identifying the optimal Regulatory submission pathway for BLA filing.
- Regulatory gap analysis (review of developmental data/analytical similarity assessment data), preparation of Regulatory mitigation plans, and Regulatory strategy for 351(a) BLA submission and 351(k) BLA submission to avoid RTF challenges.
- Regulatory consulting on biologics drug development programs and request for expedited review program designations (fast track, breakthrough therapy, accelerated review, & priority review).
- Regulatory strategy for HA queries, Complete Response Letters (CRLs) preparation, and on-time submission of responses to the US FDA queries.
- Regulatory support in scheduling BLA meetings (Type A, B, C, and BPD meetings for Biosimilars) and various Agency interactions.
- The compilation, technical review, finalization, and submission of the BLA package for several biological/biosimilar products (vaccines, recombinant therapeutic protein products, monoclonal antibody products, cellular and gene therapy products, etc.)
- Request for Regenerative Medicine Advanced Therapy (RMAT) designation for cell therapy, therapeutic tissue engineering product, or human cell and tissue products.
- Regulatory support for post-approval LCM submissions (supplements PAS, CBE 30, and CBE/BLA annual reports).
