Biologics License Applications Submission

 

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.).
Biologics License Applications Submission
  • 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.
Biologics License Applications Submission

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​