Trial Profile

Phase I, Double-Blind, Randomized, Three-Arm, Parallel-Group, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers to Evaluate Bioequivalence of LusiNEX and Tocilizumab (EU and US)

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 04 Apr 2025

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At a glance

26 Mar 2025 According to Mochida Pharmaceutical media release based on the data from this study, company submitted application for manufacturing and marketing approval of Tocilizumab biosimilar in Japan.
15 Jan 2025 Results presented in a Mochida Pharmaceutical Media Release.
15 Jan 2025 According to a Gedeon Richter Media Release, based on the positive topline results from the phase 1 and phase 3 studies of RGB-19, Richter expects to file for marketing authorization applications for RGB-19 in major European markets in the coming months, while Mochida expects to file for marketing authorization application for RGB-19 in Japan.

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