Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

Gopi Shankar1, Steven Arkin2, Laurent Cocea3, Viswanath Devanarayan4, Susan Kirshner5, Arno Kromminga6, Valerie Quarmby7, Susan Richards8, Christian K. Schneider9, Meena Subramanyam10, Steven J. Swanson11, Daniela Verthelyi5, Sarah Yim12
1Janssen Research & Development, LLC (Johnson & Johnson), 1400 McKean Road, P.O. Box 776, Spring House, Pennsylvania, 19477, USA
2Pfizer Worldwide Research & Development, Cambridge, Massachusetts, USA
3CERB/Clinical Evaluation Division, Health Canada, Ottawa, Ontario, Canada
4AbbVie, Inc., Chicago, Illinois, USA
5CDER/Office of Therapeutic Proteins, US Food and Drug Administration, Rockville, Maryland, USA
6IPM Biotech GmbH, Hamburg, Germany
7Genentech, South San Francisco, California, USA
8Sanofi, Framingham, Massachusetts, USA
9Danish National Health and Medicines Authority, Copenhagen, Denmark
10Biogen Idec, Inc., Cambridge,Massachusetts, USA
11Amgen, Inc., Thousand Oaks, California, USA
12Division of Pulmonary, Allergy and Rheumatology Products, US Food and Drug Administration, Rockville, Maryland, USA

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