Shein-Chung Chow

A Proposal for the Use of an Innovative Two-Stage PK-Clinical Adaptive Trial in Biosimilar Product Development

For approval of biosimilar drug products, the United States Food and Drug Administration (FDA) recommends a stepwise approach for obtaining the totality-of-the evidence for demonstration of the biosimilarity between a proposed biosimilar product and its reference (innovative) product. The stepwise approach consists of...