The 'totality-of-the-evidence' approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product

McClellan, JE; Conlon, HD; Bolt, MW; Katfayan, V; Palaparthy, R; Rehman, MI; Kirchhoff, CF

McClellan, JE (reprint author), Pfizer Inc, Biosimilars Dev, 235 East 42nd St, New York, NY 10017 USA.

THERAPEUTIC ADVANCES IN GASTROENTEROLOGY, 2019; 12 ():

Abstract

The 'totality-of-the-evidence' biosimilarity concept requires that sufficient structural, functional, nonclinical, and clinical data are acquired in a......

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