Two New Stelara Biosimilars Now Available in US
Yesintek from Biocon Biologics and Pyzchiva from Sandoz will have a patient assistance program that includes benefits verification and copay support.
Ustekinumab (Stelara) biosimilars ustekinumab-kfce (Yesintek) and ustekinumab-ttwe (Pyzchiva) are now available to patients across the United States, Biocon Biologics and Sandoz announced in news releases.1,2 The therapies, which are FDA approved to treat some chronic inflammatory diseases, are among the first Stelara biosimilars to enter the country’s market.
Two New Stelara Biosimilars Now Available in US / Semi - stock.adobe.com
Yesintek and Pyzchiva are both approved to treat moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis in adult patients, as well as moderate to severe plaque psoriasis and active psoriatic arthritis in pediatric patients aged 6 years and older. The therapies are available in 45 mg/0.5 mL and 90 mg/mL pre-filled syringes, 45 mg/0.5 mL subcutaneous single-dose vials, and 130 mg/26 mL single-dose vials for intravenous injection.
“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,” Leah M Howard, JD, president and CEO of the National Psoriasis Foundation, said in a release.2 “Biosimilars offer great potential for putting these effective treatment options within reach of those who may have been previously unable to afford them.”
The approval of Yesintek occurred in December 2024 and was based on data from the STELLAR-2 trial (NCT05335356). The phase 3 randomized, double-blind, active-controlled, parallel-group, multicenter study compared the efficacy, safety, immunogenicity, and pharmacokinetics of the therapy to Stelara in 384 adult patients with moderate to severe chronic plaque psoriasis. The study showed that there were no clinically meaningful differences between Yesintek and Stelara.
Pyzchiva was granted approval in January 2024 based on data from multiple studies, including a phase 3 study comparing its efficacy, safety, pharmacokinetics, and immunogenicity to Stelara in 249 patients with moderate to severe plaque psoriasis.3 The study showed that the adjusted difference of Psoriasis Area and Severity Index change from baseline and the Physician's Global Assessment and Dermatology Life Quality Index were comparable between the therapies. The overall rate of adverse events were also comparable.
Biocon said that Yesintek will have commercial payor coverage and a patient assistance program that includes benefits verification and copay support. For patients who meet certain criteria, the therapy could be available for a $0 copay. Sandoz also said it is providing similar comprehensive support resources to patients for Pyzchiva.
"The launch of Yesintek marks a significant step in our commitment to improving the lives of patients with inflammatory conditions and expanding access to high-quality biosimilars,” said Shreehas Tambe, CEO and managing directorof Biocon, in a release.1 “It also represents our first product launch in the United States since becoming a fully integrated global biosimilars organization. We are excited to be among the first companies to introduce a high-quality, affordable biosimilar ustekinumab to this patient population."
The availability of Yesintek and Pyzchiva follows the recent launch of other Stelara biosimilars to the US market. Last week, Teva and Alvotech announced that ustekinumab-aekn (Selarsdi) was available to patients.4 Additionally, Amgen’s ustekinumab-auub (Wezlana) was launched through Nuvalia, a biosimilar procurement business.5
READ MORE: Biosimilar Resource Center
Pharmacy practice is always changing. Stay ahead of the curve: Sign up for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips straight to your inbox.
