Samsung Bioepis Launches Cost-Effective PYZCHIVA in the US
United States, Monday, 24 February 2025.
Samsung Bioepis’s new biosimilar PYZCHIVA enters the US market, promising more affordable treatment for inflammatory conditions like psoriasis, potentially lowering healthcare costs and enhancing system sustainability.
Market Entry and Therapeutic Applications
Samsung Bioepis has officially launched PYZCHIVA® (ustekinumab-ttwe) in the United States on February 21, 2025 [1]. The biosimilar, which references Stelara (ustekinumab), 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 ulcerative colitis [1]. This launch represents Samsung Bioepis’s fifth biosimilar and third immunology biosimilar in the US market [1], potentially benefiting approximately 12 million patients with these conditions [3].
Treatment Accessibility and Administration
PYZCHIVA is being made available in multiple formulations to accommodate various treatment protocols, 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]. The medication’s distribution is being handled through Samsung Bioepis’s commercialization partner Sandoz, following an agreement established in September 2023 [2]. Notably, the treatment is expected to offer interchangeability in the first half of 2025 [3][alert! ‘exact interchangeability date pending regulatory confirmation’].
Safety Profile and Medical Considerations
Healthcare providers should be aware of important safety considerations when prescribing PYZCHIVA. Patients must receive all age-appropriate immunizations before initiating therapy, and live vaccines should be avoided during treatment [1]. The most commonly reported adverse reactions include nasopharyngitis, upper respiratory tract infection, headache, and fatigue [1]. In post-approval observations, cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported, requiring careful monitoring and potential treatment discontinuation if such conditions develop [1].
Market Impact and Healthcare Economics
The introduction of PYZCHIVA represents a significant development in the biosimilars landscape. Linda Y. MacDonald, Executive Vice President at Samsung Bioepis, emphasizes that this launch marks a crucial milestone for both the company and patients, potentially reducing healthcare costs and contributing to a more sustainable healthcare system [1]. Supporting this perspective, Leah M. Howard, President and CEO of the National Psoriasis Foundation, notes that biosimilars offer significant potential for making effective treatment options more accessible to patients [3]. Samsung Bioepis currently maintains a robust portfolio of 11 biosimilars, with 10 approved and five commercially available in the US market [1].