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  • Equivalence of Complex Drug Products

    Scientific and Regulatory Challenges

    Equivalence of Complex Drug Products

    Scientific and Regulatory Challenges

    Organizers: Melanie Brickman Borchard (The New York Academy of Sciences), Alison Carley (The New York Academy of Sciences), Daan J.A. Crommelin (Utrecht University), Wenlei Jiang (US Food and Drug Administration), Scott McNeil (Nanotechnology Characterization Laboratory), Vinod Shah (Non Biological Complex Drugs Working Group), and Jon de Vlieger (Lygature)Presented by the Non Biological Complex Drugs Working Group (NBCD WG), the Nanotechnology Characterization Laboratory (NCL) of the Frederick National Lab for Cancer Research, and the New York Academy of Sciences
    Reported by Jennifer Cable | Posted February 28, 2017

    Overview

    Biotechnology and nanotechnology have given rise to a growing number of innovator-driven complex drug products and their copy versions. Biologics exemplify one category of complex drugs, but there also exist non-biological complex drug products (NBCDs), including many nanomedicines such as iron-carbohydrate complexes, several drug carrying liposomes or emulsions, and glatiramoids. These products are difficult to characterize—often the key features for efficacy and safety are not well understood. These factors pose unique challenges for pharmaceutical companies and regulatory agencies when comparing generic complex drugs to their branded counterparts.

    On November 9, 2016, representatives from academia, industry, and regulatory agencies convened at the New York Academy of Sciences for the symposium Equivalence of Complex Drug Products: Scientific and Regulatory Challenges, an opportunity to discuss how to approach complex generics. Regulatory officials described how agencies approach evaluating complex generics for marketing approval, while industry speakers presented several examples that demonstrate the difficulties in characterizing complex drugs.

    The symposium was presented by the Non Biological Complex Drugs Working Group, the Nanotechnology Characterization Laboratory, and the New York Academy of Sciences.

    Use the tabs above to find a meeting report and multimedia from this event.

     

    Presentations available from:
    Daan J.A. Crommelin, PhD (Utrecht University)
    Scott McNeil, PhD (Nanotechnology Characterization Laboratory)
    Wenlei Jiang, PhD (Office of Research and Standards, Office of Generic Drugs, U.S. Food and Drug Administration)
    Jon de Vlieger, PhD (Lygature)
    Stephan Stern, PhD, DABT (Nanotchnology Characterization Laboratory)
    Gary West, MD (Azaya Therapeutics)
    Stefan Mühlebach, PhD (Vifor Pharma Ltd)
    Lawrence Mayer, PhD (Jazz Pharmaceuticals)
    Elena Wolff-Holz, MD (Paul Ehrlich Institute)
    Wyatt Vreeland, PhD (The National Institute of Standards and Technolgy)
    Gillian Wollettt, DPhil, MA (Avalere Health)
    Elwyn Griffiths, PhD, DSc (World Health Organization and Health Canada)
    Iris Grossman, PhD (Teva Pharmaceuticals)
    Beat Flühmann, PhD (Vifor Pharma Ltd)


    Presented by

    • Non Biological Complex Drugs Working Group (NBCD WG)
    • Nanotechnology Characterization Laboratory (NCL) of the Frederick National Lab for Cancer Research
    • The New York Academy of Sciences

    How to cite this eBriefing

     

    The New York Academy of Sciences. Equivalence of Complex Drug Products: Scientific and Regulatory Challenges. Academy eBriefings. 2016. Available at: www.nyas.org/ComplexDrugs16-eB

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