Bio-Thera Gets Chinese Nod To Proceed On Ustekinumab
China’s NMPA Gives Go-Ahead For Phase I Trial On Stelara Biosimilar
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.
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China’s Bio-Thera solutions has announced the start of Phase I trials for its ustekinumab biosimilar. The project is one among several potential rivals to Stelara in the works from a host of developers.
Australia’s NeuClone has reported the completion of subject visits in its Phase I trial for a biosimilar ustekinumab rival to Janssen’s Stelara, with favorable results seen ahead of the formal study report that is due in the third quarter of this year.
China’s Bio-Thera Solutions has reported positive Phase III results for its proposed bevacizumab biosimilar rival to Avastin.