1. Generics Bulletin

Bio-Thera Gets Chinese Nod To Proceed On Ustekinumab

China’s NMPA Gives Go-Ahead For Phase I Trial On Stelara Biosimilar

 
• By Penelope MacRae

China’s Bio-Thera Solutions has received approval from the country’s NMPA to launch a Phase I clinical study comparing the pharmacokinetics and safety of its proposed ustekinumab biosimilar to Johnson & Johnson’s blockbuster psoriasis drug Stelara, the latest in a string of the biotech company’s products to advance into clinical development.

China
China has given Bio-Thera approval to proceed with a Phase I ustekinumab trial • Source: Shutterstock

Bio-Thera Solutions has received the regulatory go-ahead from the China National Medical Products Administration to carry out a Phase I clinical study on its proposed biosimilar of Johnson & Johnson’s top-selling psoriasis drug Stelara (ustekinumab).

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