Back to: FDA Generic Drug Science and Research Initiatives Public Workshop 2025
Presenters
Challenges and Opportunities Related to the Development of Generic Drugs
Anna Schwendeman, PhD
Co-Director, CRCG
Professor, University of Michigan
Closing Remarks
Robert Lionberger, PhD
Director, Office of Regulatory Science (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Abstract
This closing session of the FY 2025 Generic Drug Science and Research Initiatives Public Workshop highlights the critical role of generic medications, which constitute 90% of drugs consumed in the U.S. despite facing increasing economic and scientific pressures. The Center for Research in Complex Generics (CRCG), a collaboration between the University of Michigan and the University of Maryland, works to bridge communication gaps and foster collaborative research among industry, academia, and the FDA. Key challenges in generic drug development include nitrosamine concerns, complex API characterization, immunogenicity of peptides and oligonucleotides, and the complexities of long-acting injectables and inhalation products. Presenters emphasize the urgent need for innovative scientific approaches, such as robust in vitro assays and biopredictive dissolution methods, to streamline development and reduce the necessity for extensive clinical trials. The session also addresses the importance of regulatory harmonization, enhancing the scientific workforce’s foundational knowledge, and exploring the potential of artificial intelligence. The FDA expresses its commitment to fostering generic competition, particularly in areas like GLP-1s, oligonucleotide therapeutics, and inhalation products, by providing direct support and encouraging investment. The CRCG is seen as vital for translating scientific needs and establishing best practices to advance generic drug development.