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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Bio-Thera Solutions has secured only the second biosimilar approval ever from China’s NMPA, and the country’s first biosimilar approval for a rival to Humira (adalimumab).
Formycon has become the latest firm to announce a Phase I trial for a proposed biosimilar ustekinumab rival to Janssen’s Stelara, following hot on the heels of NeuClone.