The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the use of Guangzhou-based Bio-Thera Solutions Ltd’s (SHA: 688177) Usymro in moderate-to-severe plaque psoriasis (PsO) in adults and children, active psoriatic arthritis (PsA) and moderate-to-severe active Crohn’s disease (CD). Usymro is a biosimilar version of Johnson & Johnson’s autoimmune disease drug Stelara (ustekinumab).
Stelara Background
Stelara is the world’s first all-human “dual-targeted” interleukin 12 (IL-12) and interleukin 23 (IL-23) inhibitor.
Global Commercialization
Bio-Thera Solutions is promoting Usymro for commercialization in multiple regions through partners including Hikma (U.S.), Pharmapark (Russia & CIS countries), Biomm (Brazil), and Gedeon Richter (Europe, Australia, etc.). Approved in the U.S. in May under the trade name Starjemza, the biosimilar is currently awaiting regulatory decisions in China.-Fineline Info & Tech
