Comparability Considerations and Challenges for Expedited Development Programs for Biological Products
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CURRENT OPINION
Comparability Considerations and Challenges for Expedited Development Programs for Biological Products Sarah J. Schrieber1 · Wendy S. Putnam2 · Edwin Chiu Yuen Chow3 · Jacek Cieslak4 · Yanli Zhuang5 · Steven W. Martin6 · Paul Hanson7 · Frank Maggio8 · Leslie A. Rivera Rosado4,9
© The Author(s) 2020
Abstract Expedited development programs for biological products to be used in the treatment of serious conditions bring about challenges because of the compressed clinical development timeframes. As expedited development does not lessen the quality expectations, one challenge is providing adequate chemistry, manufacturing, and control (CMC) information required to support approval of a biological product. In particular, the analytical comparability and, in some cases, pharmacokinetic comparability studies needed to bridge the clinical material to the commercial material could delay submission of applications for life-saving medicines. While there is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Topic Q5E guidance on assessing comparability of biological products before and after manufacturing changes, specific guidance on the emerging issue of conducting comparability exercises in the face of expedited drug development is lacking. In July 2019, clinical pharmacologists and product quality chemists from the US FDA and industry representatives convened an FDA workshop for a scientific exchange about considerations and challenges around conducting comparability exercises for expedited programs for biological products. This article highlights discussions from the workshop.
Sarah J. Schrieber and Wendy Putnam share co‐first authorship. The views expressed in this article are those of the authors and do not necessarily reflect the views or policies of the FDA. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40268-020-00321-4) contains supplementary material, which is available to authorized users. * Sarah J. Schrieber [email protected] 1
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Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20903, USA Department of Clinical Pharmacology, Genentech, Inc., South San Francisco, CA, USA
3
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
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Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
5
Clinical Pharmacology and Pharmacometrics, Janssen Research & Development, LLC, Spring House, PA, USA
6
Pharmacometrics Group, Department of Clinical Pharmacology, Global Product Development, Pfizer Inc., Cambridge, MA, USA
7
Global Manufacturing and Supply, Takeda Pharmaceuticals International Co, Cambridge, MA, USA
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