Samsung Bioepis has introduced PYZCHIVA, a Stelara biosimilar, in the US market to treat psoriasis, Crohn’s, and ulcerative colitis, aiming to provide more accessible and affordable healthcare options.
Market Entry and Treatment Scope
Samsung Bioepis officially launched PYZCHIVA® (ustekinumab-ttwe) in the United States on February 21, 2025 [1]. The biosimilar, which represents Samsung Bioepis’ fifth biosimilar and third immunology treatment in the US market [4], has received FDA approval for treating multiple inflammatory conditions, including moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis [1][2]. This launch is particularly significant as it aims to serve approximately 12 million patients across these conditions [2].
Treatment Accessibility and Cost Impact
The introduction of PYZCHIVA marks a significant advancement in making critical treatments more accessible. According to Leah M. Howard, President and CEO of the National Psoriasis Foundation, ‘Biosimilars offer great potential for putting these effective treatment options within reach of those who may have been previously unable to afford them’ [2]. The drug is being made available in multiple formats to accommodate various treatment needs, including 45 mg/0.5 mL and 90 mg/mL pre-filled syringes, 130 mg/26 mL intravenous infusion single-dose vial, and 45 mg/0.5 mL subcutaneous vials [1].
Strategic Partnership and Market Position
Samsung Bioepis has partnered with Sandoz for the commercialization of PYZCHIVA in the US market, an agreement established in September 2023 [1]. This collaboration is part of Sandoz’s broader strategy to become the leading biosimilar provider in the United States [2]. The timing of this launch is strategic, with interchangeability status expected in the first half of 2025 [2]. Currently, Samsung Bioepis maintains a robust portfolio of 11 biosimilars across various therapeutic areas, with 10 approved in the US and five now commercially available [1].
Safety and Patient Support
Healthcare providers and patients should note important safety considerations with PYZCHIVA. Patients are advised to avoid live vaccines during treatment and should complete all age-appropriate immunizations before beginning therapy [5]. To support patient access, Sandoz is implementing comprehensive support resources, including insurance coverage assistance, self-injection training, and a co-pay program [2]. This support system aims to ensure that patients can effectively access and utilize this new treatment option while maintaining safety standards.