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Using Clinical PK/PD Studies to Support No Clinically Meaningful Differences Between a Proposed Biosimilar and the Reference Product

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Acknowledgements

We would like to give special thanks to Vincent Chow (Amgen Inc.) for providing invaluable insights and suggestions for this article. We also would like to acknowledge Sherwin K. B. Sy (Novartis Pharmaceuticals Corporation), Stacey Ricci (FDA), Sue Limb (FDA), Rajnikanth Madabushi (FDA), and Sarah J Schrieber (FDA) for their thoughtful inputs and kind help in editing this article.

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Authors and Affiliations

  1. Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, New Jersey, 07996, USA

    Peijuan Zhu

  2. Food and Drug Administration, Silver Spring, Maryland, USA

    Ping Ji & Yaning Wang

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  1. Peijuan Zhu
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  2. Ping Ji
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  3. Yaning Wang
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Correspondence to Peijuan Zhu.

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Zhu, P., Ji, P. & Wang, Y. Using Clinical PK/PD Studies to Support No Clinically Meaningful Differences Between a Proposed Biosimilar and the Reference Product. AAPS J 20, 89 (2018). https://doi.org/10.1208/s12248-018-0246-1

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