Samsung Bioepis and Sandoz launch Pyzchiva in USSamsung Bioepis and Sandoz launch Pyzchiva in US

Drug developer Samsung Bioepis and generic and biosimilar manufacturer Sandoz have launched Pyzchiv (ustekinumab), a monoclonal antibody (mAb) medication which is now commercially available to patients in the US. Pyzchiva is a biosimilar to Stelara, and it has been approved to treat patients with moderate to severe plaque psoriasis who meet certain conditions.

Sandoz successfully launched Pyzchiva in Europe last year. “We already have a strong presence in immunology and this product will allow us to leverage our existing infrastructure,” said CEO Richard Saynor in August 2024 while assessing the drug’s impact.  

Sandoz and Samsung Bioepis entered into a partnership in September 2023, wherein Sandoz agreed to commercialize Samsung Bioepis’s then unnamed biosimilar. The drug seeks to give patients an affordable alternative to Stelara, which can be prohibitively expensive for patients without insurance coverage.

“Pyzchiva offers an affordable option for patients who could benefit from treatment with ustekinumab and aims to elevate the patient experience with extended stability, including the ability to be re-refrigerated unlike the reference medicine,” a spokesperson for Sandoz told BioProcess Insider. “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 provides a prefilled syringe option, allowing patients to administer it from the comfort of their home.”

The spokesperson added that Sandoz will offer support resources to prescribed patients, including insurance support/benefit investigation, injection support, and a copay program for commercially insured patients.

“The launch of Pyzchiva is a significant milestone for both Samsung Bioepis and for millions of patients living with inflammatory conditions in the US," said Linda MacDonald, EVP and head of global commercial division at Samsung Bioepis. "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.”

“This is an important moment for millions of patients living with chronic autoimmune diseases,” said Keren Haruvi, president of Sandoz North America. “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.”

The spokesperson confirmed that Sandoz has the rights to commercialize Pyzchiva in the US, the European Economic Area, Switzerland, the UK, Brazil, and Canada.