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Yesintek and Pyzchiva, Two Stelara Biosimilars, Now Available in the US

Yesintek (ustekinumab-kfce) and Pyzchiva (ustekinumab-ttwe) are now available in the US.

Biocon Biologics Ltd’s Yesintek is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Yesintek will be available in all the same formulations currently provided by Stelara. The available presentations are 45mg/0.5mL pre-filled syringes, 90 mg/mL pre-filled syringes, 45mg/0.5mL vial, and 130mg/26mL vial.

Samsung Bioepis Co., Ltd’s Pyzchiva is commercialized by Sandoz. It is also approved for the same indications as reference medicine Stelara. Unlike Stelara, Pyzchiva can be re-refrigerated. Pyzchiva is available in 45mg/0.5mL and 90mg/mL pre-filled syringes, 130 mg/26mL single-dose vials for intravenous injection, and 45mg/0.5mL subcutaneous single-dose vials.

Yesintek will have commercial payor coverage at launch and a patient assistance program that includes benefits verification, copay support, among other services. The copay program is competitive with the originator offering and eligible patients that meet the program criteria may pay as little as $0. 

Sandoz is providing support resources for patients who are prescribed Pyzchiva, including information about insurance coverage/benefit investigation, self-injection training, and a co-pay program for commercially insured patients.

“Psoriasis and psoriatic arthritis are chronic diseases that can be treated with biologics, but those medications are often not as accessible or affordable as they should be for those who could benefit most from them,” says Leah M. Howard, JD, the President and CEO of the National Psoriasis Foundation in a news release on the availability of Pyzchiva. “Biosimilars offer great potential for putting these effective treatment options within reach of those who may have been previously unable to afford them.”