Johnson & Johnson (J&J, NYSE: JNJ)’s auto-immune disease drug Stelara (ustekinumab) is set to encounter another potential competitor in the Chinese market. CSPC Pharmaceutical Group Ltd (HKG: 1093), a local firm, has recently announced that the National Medical Products Administration (NMPA) has accepted its market filing for review, marking a significant step towards offering a biosimilar alternative to Stelara.
Stelara’s Global and Chinese Market Presence
Stelara, the world’s first all-human “dual-targeted” inhibitor of interleukin 12 (IL-12) and interleukin 23 (IL-23), has garnered five indication approvals in the US, addressing conditions such as ulcerative colitis, Crohn’s disease, active psoriatic arthritis, and various forms of psoriasis. Since its initial approval in China in 2017, Stelara has been a prominent player in the treatment of auto-immune diseases.
CSPC’s Biosimilar Efficacy and Safety Profile
Clinical studies have demonstrated that CSPC’s biosimilar version of Stelara is comparable to the original drug in terms of efficacy and safety. This equivalence is particularly relevant for patients with moderate to severe plaque psoriasis, offering a potential alternative that maintains therapeutic standards.
Market Competition with Huadong Medicine Co., Ltd
The entry of CSPC’s biosimilar into the review process follows the recent launch of Huadong Medicine Co., Ltd’s (SHE: 000963) own Stelara copycat in China. This development indicates a growing competitive landscape for biosimilars in the Chinese market, with multiple companies vying to provide cost-effective alternatives to established biologics.-Fineline Info & Tech
