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Session 5B: Challenges in Development and Approval of Generic Non-Biological Complex Drugs (NBCDs)
Session Chair(s)
Yu Chung Tsang, PhD
Chief Science Officer, Biopharmaceuticals and Biostatistics, Apobiologix
Apotex Inc., Canada
Non-biological complex drugs (NBCDs) are defined scientifically as not being a biological medicinal product where the active substance is not a homo-molecular structure, but consists of different closely related and often nanoparticulate structures that cannot be isolated and fully quantitated, characterized and/or described by physicochemical analytical means, where the structural elements that might impact the therapeutic performance are unknown. Nanomedicines, such as liposomes, polymeric micelles, glatiramoids, iron-carbohydrate complexes and nanocrystals are examples of NBCDs. The challenges in developing analytical methodologies to characterize these products, as well as assuring safety and efficacy of generic NBCDs for regulatory approval will be presented and discussed in this session.
Speaker(s)
Regulatory Perspective on Demonstrating Analytical and Therapeutic Similarities of Complex Generic Products
Robert A. Lionberger, PhD
FDA, United States
Director, Office of Research and Standards, Office of Generic Drugs, CDER
Challenges in Manufacture of NBCDs and Assuring Analytical Similarity
Olu Aloba
Camargo, United States
Senior Director, Pharmaceuticals
The Need of Conducting Clinical Study for Assuring Safety and Efficacy, as Well as a Lack of Immunogenicity for Generic NBCDs
Ajaz S Hussain, PhD
Insight Advice & Solutions LLC, United States
President & CEO
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