FDA Expectations for Demonstrating Interchangeability

Chance, K

Chance, K (reprint author), KC Biopharma Consulting LLC, 4920 E Greensboro Chapel Hill Rd, Graham, NC 27253 USA.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2018; 52 (3): 369

Abstract

There is a great interest from global companies who are developing biosimilars to pursue interchangeability designation for commercialization of their......

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