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mAbs Volume 8, 2016 - Issue 3
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Perspective

Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges

Kathryn ChapmanNational Center for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), UKCorrespondence[email protected]
,
Akosua AdjeiMedicines and Healthcare Regulatory Agency (MHRA), UK
,
Paul BaldrickCovance Laboratories, Harrogate, UK
,
Antonio da SilvaSandoz, Holzkirchen, Germany
,
Karen De SmetFederal Agency for Medical and Health Products (FAMHP), Belgium
,
Richard DiCiccoHarvest Moon Pharmaceuticals, US
,
Seung Suh HongCelltrion, Japan
,
David JonesMedicines and Healthcare Regulatory Agency (MHRA), UK
,
Michael W. LeachPfizer, US
,
James McBlaneMedicines and Healthcare Regulatory Agency (MHRA), UK
,
Ian RaganIndependent, UK
,
Praveen ReddyBiocon, India
,
Donald I. H. StewartPlantform Corp, Canada
,
Amanda SuittersParaxel, UK
&
Jennifer SimsIntegrated Biologix, Switzerland
 show all
Pages 427-435 | Received 06 Nov 2015, Accepted 19 Jan 2016, Published online: 24 Mar 2016

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