$349 USD

The Biologics License Application (BLA) for Marketing Approval in the USA

Learn how to complete a Biologics License Application (BLA) to request the Food and Drug Administration (FDA) to license the sale and marketing of a biological product in the US.

  • English
  • Certificate of completion
  • 4.5 Hours
  • Regulatory / Quality Assurance
  • 1 Year

Overview

Formulating biologics is an intense and complex process that requires strict adherence to regulations. Any sponsor wanting to market and sell a biologic must receive a license to do so from the Food and Drug Administration (FDA). The application for this license centers around the Biologics License Application (BLA).

Biological products have come to dominate the market for medicines in recent decades. To introduce a biological product into interstate commerce in the USA, the sponsor of the product must gain FDA approval of a Biologics License Application (BLA). This enormous compilation of information and data is the culmination of years of effort and financial investment by the sponsor company in the research and development of the product. Biological products require manufacturing processes of greater complexity than those for small-molecule drugs, and control of the processes is critical to assurance of the products’ safety, purity and potency. The processes and manufacturing establishments are subject to extensive inspection by the FDA before approval.

This course is intended primarily for regulatory affairs professionals who are new to the BLA or who are seeking a refresher course. It will also be of interest to others involved in drug development and/or who interact with the FDA. It will take a dive deep into the role of the BLA, including reviewing key criteria for licensure, the expected process control and manufacturing procedures, and the procedural requirements for its submission to the FDA.

The course covers:

  • Introduction – It is important to understand the role of the BLA, define what constitutes a biological product, and outline the legal basis for regulating such products in the United States. The key criteria for licensure of biologics are clearly defined. The Centers within the US Food and Drug Administration (FDA) to which a BLA must be submitted for review and approval are identified based on the type of product. The importance of maintaining effective communication between the agency and the sponsor of a BLA before submission is emphasized. Additionally, the high-level structure of the electronic Common Technical Document (eCTD), which must be followed for BLA submissions, is described.
  • Quality information – Biologics manufacture involves many complex processes, which must be described in the parts of the eCTD concerning the quality of the product. Learn the characteristics of biologics manufacture and outline the chemistry, manufacturing, and controls (CMC) information that needs to be included in a BLA.
  • INonclinical information – Get an overview of the information required on pharmacological actions, toxicological effects, pharmacokinetics, and reproductive toxicity from studies in animals.
  • Clinical information – Module 5 of a BLA, containing clinical information, is the largest and most complex part of the application. The data and analyses it provides are key to the FDA’s understanding of the safety and effectiveness of the biological product. Gain an understanding of the components of the information required, according to the categorization of form FDA 356h.
  • Administrative information and summaries – Get an overview of Modules 1 and 2 of a BLA. Module 1 contains administrative and prescribing information specific to the USA, including the draft labeling for the product. Module 2 contains summaries and overviews of the quality, nonclinical, and clinical information included in Modules 3 to 5 of the application.
  • BLA submission and FDA review – By submission of a BLA to the FDA’s Center for Biologics Evaluation and Research (CBER) or Center for Drug Evaluation and Research (CDER), a sponsor formally proposes that the agency license a new biological product for sale and marketing in the USA. To gain a biologics license the applicant must convince the reviewers that their product is safe, pure, and potent. Lern the details the process of BLA submission and review, including the FDA’s responsibilities and actions, the obligations of the applicant, and the options available.
  • Expedited development and review – The FDA has established several processes that enable patients to access new medicines earlier than would be the case under the normal development and review process. In this section, we describe four mechanisms potentially available to sponsors of biological products regulated by CDER or CBER that address unmet medical needs in treating a serious condition: priority review, accelerated approval, fast-track development, and breakthrough therapy designation. Learn about the most recently introduced expedited program, applicable to some products regulated by CBER: regenerative medicine advanced therapy designation.

Learn

  • The requirements for obtaining a license to market and sell biologics in the US
  • What process control and manufacturing criteria the Food and Drug Administration (FDA) require
  • To identify the content and format requirements for a BLA
  • To ensure the BLA also complies with the International Council for Harmonization (ICH)
  • To understand FDA requirements for expedited drug development and review
Read full overview

Agenda

1. Section 1: Module Overview

2. Section 2: Introduction

3. Section 3: Quality Information

4. Section 4: Nonclinical Information

5. Section 5: Clinical Information

6. Section 6: Administrative Information and Summaries

7. Section 7: BLA Submission and FDA Review

8. Section 8: Expedited Development and Review

9. Section 9: Assessment

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