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Meiji Seika Is Latest To Kick Off Ustekinumab Phase III

Sees Positive Phase I Results For Stelara Biosimilar With Dong-A Socio Holdings

 
• By Dave Wallace

Meiji Seika and Dong-A Socio Holdings have become the latest developers to announce the start of Phase III trials for an ustekinumab biosimilar rival to Stelara.  

Starting blocks sprint race
Several companies are jostling for position on biosimilar Stelara • Source: Alamy

Japan’s Meiji Seika Pharma and Korea’s Dong-A Socio Holdings have announced the start of Phase III trials for their DMB-3115 proposed biosimilar rival to Stelara (ustekinumab) following “promising” Phase I results for the inflammatory diseases treatment.

Equivalence to Stelara “has been demonstrated in a Phase I clinical trial compared to the reference products marketed in Europe and the US,” the firms indicated, describing the “randomized double-blind, three-arm, single-dose study to compare pharmacokinetics, safety and tolerability

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