Blog Big Molecule Watch May 26, 2021

Meiji Announces Promising Phase I Results for Ustekinumab Biosimilar and Initiation of Phase III Clinical Trial

On May 21, 2021, Meiji Seika Pharma Co, Ltd. announced that phase I clinical trials of DMB-3115, its proposed ustekinumab (STELARA®) biosimilar, demonstrated bioequivalence to reference products marketed in Europe and the United States.  Meiji is co-developing ustekinumab under a 2011 strategic collaboration partnership agreement with Dong-A Socio Holdings.  Phase III multi-regional clinical trials of 45 mg and 90 mg subcutaneous injections of DMB-3115, in patients with plaque psoriasis, have been initiated in Europe and the United States.

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