On December 2, Biocon Biologics announced that it had received FDA approval for Yesintek (ustekinumab-kfce), the sixth authorized biosimilar to Stelara (so far).
The Yesintek approval assures Biocon Biologics that it will be able to launch its latest biosimilar in the middle of the pack, along with Fresenius Kabi, Samsung Bioepis, and Sandoz, no later than February 22, 2025 (Amgen will launch first, with Wezlana, on January 1). The approval was supplemented by a phase 3 trial in patients with chronic plaque psoriasis.
Formerly designated Bmab 1200, Yesintek is approved to treat patients with Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The drug will be available in both 45 mg/0.5 mL and 90 mg/mL prefilled syringes, single-dose vial, and 130 mg/26 mL single-dose vial for intravenous infusion.
Additional competition may come from Celltrion’s CT-P43 and Bio-Thera’s BAT-2206, both of which are awaiting approval.
At least one of these products (Wezlana, and likely others) will be heading down the PBM private-label path. We also assume that the reference manufacturer, Johnson & Johnson, will produce an unbranded version of Stelara, to duplicate their strategy for infliximab biosimilars.
