Innovation and Competition: Will Biosimilars Succeed?: The creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. But so are efficacy and patient safety

Biotechnol Healthc. Spring 2012;9(1):24-7.

Abstract

Biosimilars are here, but there's no clear pathway yet for their approval. Difficult realities about their effect on drug prices, innovation, and competition need to be faced.