TROIKA‐1: A double‐blind, randomized, parallel group, study aimed to demonstrate the equivalent pharmacokinetic profile of HD201, a potential biosimilar candidate to trastuzumab, versus EU‐Herceptin® and US‐Herceptin® in healthy male subjects

• Main Authors: Martin Demarchi (Author), Pierre Coliat (Author), Kristi Mclendon (Author), Jocelyn Chung Shii Hii (Author), Peggy Feyaerts (Author), Felicia Ang (Author), Litha Jaison (Author), Filip Deforce (Author), Marie Paule Derde (Author), Michael Jinwoo Kim (Author), Lisa Soyeon Park (Author), Alexandre Detappe (Author), Xavier Pivot (Author)
• Format: Book
• Published: Wiley, 2021-08-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract Prestige Biopharma Ltd (Singapore) has developed HD201, a proposed biosimilar to reference product trastuzumab. As a part of the stepwise approach to ensure comparability between the biosimilar candidate and the reference medicinal product, a phase I study in healthy subjects was conducted...