Blog Big Molecule Watch August 05, 2022

Celltrion Files IND with FDA for Adalimumab Biosimilar

As reported by Pulse and DailyPharm Korea, Celltrion recently filed an Investigational New Drug (IND) application with the FDA for a global Phase 3 clinical trial aimed at demonstrating its biosimilar’s (YUFLYMA) interchangeability with HUMIRA (adalimumab).  The trial will evaluate the pharmacokinetics, efficacy, and safety of YUFLYMA in 366 patients with plaque psoriasis.  Celltrion submitted its application to the FDA for approval of YUFLYMA in November 2020, and plans to launch YUFLYMA in the United States in 2023.

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