Biologics are complex drugs that are manufactured using living cells, microorganisms, or recombinant DNA technology. They are used to treat a variety of diseases, including cancer, autoimmune disorders, and infectious diseases. Biosimilars are drugs that are highly similar to, but not identical to, an approved biologic drug. They are developed to be comparable in terms of safety, efficacy, and quality, and are often used as more affordable alternatives to the original biologic drug.
To gain approval for a biologic or biosimilar drug, a manufacturer must submit a Biologics License Application (BLA) or a biosimilar application to the appropriate regulatory agency, such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). These applications must include data from preclinical and clinical studies, as well as information on the manufacturing process and product quality.
This course discusses basic biologics and biosimilars submission concepts and reviews FDA recommendations for developing biologics, including requirements for preclinical, clinical
and Chemistry, Manufacturing, and Control development to support regulatory submissions.
It, also, reviews biologic promotional, post-marketing compliance and commercial manufacturing and supply.
Learning Points:
- History of Biologic Products
- Organizational Structure and Responsibilities of the Center for Biologics Evaluation and Research (CBER) and the Center Pre-Marketing and Post-Marketing Requirements for Drug Evaluation and Research (CDER) in Reviewing Premarket Biologics Submissions
- Investigational New Drug (IND) Process
- Biologic License Application (BLA) Contents and the BLA Review Process
- Regulatory Compliance Principles for Biologics Pre-approval
- Regulatory Post-Approval Compliance Principles for Biologics
- Risk Management Plans for Biologics
- FDA Enforcement Activities for Biologics
- FDA Biologics Labeling and Promotion Requirements
- Basic Concepts of Biosimilar Regulatory Submissions
- Similarities and Differences Between Biosimilar and Biologics Application Submissions
- FDA recommendations for developing biosimilars