Biopharmaceutical company Samsung Bioepis has announced the US launch of Pyzchiva (ustekinumab-ttwe), a biosimilar to Stelara.
Pyzchiva is approved to treat moderate to severe plaque psoriasis, active psoriatic arthritis, and moderate to severe Crohn’s disease and ulcerative colitis.
It is available through Samsung Bioepis’ commercialisation partner, Sandoz, in 45 mg/0.5 mL and 90 mg/mL pre-filled syringes, 130 mg/26 mL intravenous infusion single-dose vials, and 45 mg/0.5 mL subcutaneous vials.
Samsung Bioepis and Sandoz formed a commercialisation agreement for ustekinumab-ttwe in the US in September 2023.
The South Korean biopharmaceutical company is responsible for development, registration, intellectual property, manufacturing, and supply.
The US license period for Pyzchiva starts on 22nd February 2025, in accordance with the settlement and license agreement with Janssen Biotech.
In July 2024, the biopharmaceutical company secured approval from the US Food and Drug Administration (FDA) for Pyzchiva.
Samsung Bioepis executive vice president and global commercial division head Linda MacDonald said: “The launch of Pyzchiva is a significant milestone for both Samsung Bioepis and for millions of patients living with inflammatory conditions in the US.
“The expanded treatment options in the market would allow for reduced healthcare costs, ultimately contributing to a more sustainable healthcare system.
“We remain steadfast in our commitment to serve patients in need through our continued innovation to make medicine more accessible.”
The drug is Samsung Bioepis’ fifth biosimilar and its third immunology biosimilar launched in the US.
Samsung Bioepis has 11 biosimilars in its portfolio across immunology, oncology, ophthalmology, haematology, nephrology, and endocrinology. Of these, 10 biosimilars are approved in the US.
In a similar development, Biocon Biologics (BBL), a biosimilar company and a subsidiary of Biocon, has launched Yesintek (ustekinumab-kfce) in the US.
Yesintek is another biosimilar of Stelara. The drug is also approved to treat Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
It is available in the same formulations as Stelara, including 45 mg/0.5 mL pre-filled syringes, 90 mg/mL pre-filled syringes, 45 mg/0.5 mL vials, and 130 mg/26 mL vials.
Biocon Biologics CEO and managing director Shreehas Tambe said: “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.
“It also represents our first product launch in the US since becoming a fully integrated global biosimilars organisation.”
