Switzerland-headquartered Sandoz (SWX: SDZ) has announced that the European Commission (EC) has granted approval for Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J; NYSE: JNJ) IL-12/23 blocker Stelara (ustekinumab), developed in partnership with South Korea’s Samsung Bioepis. Both biologics are indicated for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease (CD), and ulcerative colitis (UC).
The approval was supported by Phase I pharmacokinetics and pharmacodynamics data, as well as a late-stage confirmatory study demonstrating the equivalence of Sandoz’s biosimilar product to J&J’s reference drug.
According to public reporting, Pyzchiva is the second ustekinumab biosimilar to be introduced in the European market, following Stada Arzneimittel’s Uzpruvo.- Flcube.com