SYSA1902 (ustekinumab biosimilar) / CSPC Pharma - LARVOL DELTA

Stelara Biosimilar SYSA1902 Shows Clinical Equivalence for Plaque Psoriasis (Pharmacy Times) - "The findings demonstrated that, at week 12, the mean percentage change from baseline in PASI was approximately 86.4% and 84.7% in the SYSA1902 and Stelara groups, respectively, with a difference of about 1.68% (95% CI –1.45 to 4.81). This fell within the equivalence margins, according to the investigators. Additionally, PASI 75 at week 12 was achieved by about 83.3% (n = 185) of patients receiving SYSA1902 compared with 79.3% (n = 172) of those treated with Stelara....Overall treatment-emergent adverse events (TEAEs) rate was 89.3% and 85.6% in the SYSA1902 and Stelara groups."

P3 data • Psoriasis

CSPC Pharmaceutical’s Ustekinumab Application Accepted in China (MSN News) - "CSPC Pharmaceutical Group has announced that its subsidiary’s biologic license application for Ustekinumab Injection, a treatment for moderate to severe plaque psoriasis, has been accepted by China’s National Medical Products Administration. This product, which closely matches the efficacy and safety profile of the originator drug Stelara, offers a promising treatment option with a convenient dosing schedule for patients who have not responded to other therapies."

China filing • Immunology • Psoriasis