Sandoz launches biosimilar Pyzchiva (ustekinumab-ttwe) in the US, offering new treatment for around 12 million patients

Sandoz, announces the launch of Pyzchiva (ustekinumab-ttwe) in the US. Developed by Samsung Bioepis Co., Ltd., and marketed by Sandoz, Pyzchiva has been approved by the FDA for the treatment of certain chronic inflammatory diseases, with the same indications as reference medicine Stelara.

Pyzchiva is a key biosimilar value driver for Sandoz, contributing to the company’s overall growth strategy.  The availability of Pyzchiva, which builds on the US launch of Hyrimoz in July 2023, marks an important step in the Sandoz strategic ambition with biosimilars in the US.

Keren Haruvi, President, Sandoz North America, said: “This is an important moment for millions of patients living with chronic autoimmune diseases.. The launch of Pyzchiva reinforces our commitment to broaden access to treatment options for patients, while helping to build a more sustainable healthcare system in the US so that everyone can access the medicines they need, when they need them.”

Pyzchiva offers an affordable option for patients who could benefit from treatment with ustekinumab. It also provides the full suite of dosing options to meet the needs of a variety of patients and is expected to offer interchangeability in the first half of 2025. Pyzchiva elevates the patient experience with extended stability, including the ability to be re-refrigerated, unlike the reference medicine.

Leah M. Howard, J.D., the president and CEO of the National Psoriasis Foundation, said: “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. Biosimilars offer great potential for putting these effective treatment options within reach of those who may have been previously unable to afford them.”

This launch is in accordance with the settlement and license agreement with Johnson & Johnson for the US market, previously announced by Samsung Bioepis Co., Ltd. Sandoz entered into a commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to market Pyzchiva in the US, Canada, the European Economic Area, Switzerland, the UK and Brazil. Samsung Bioepis Co., Ltd. remains responsible for development, registration, intellectual property, manufacturing and supply.