Sandoz has officially launched Pyzchiva® (ustekinumab-ttwe) in the United States, marking a significant advancement in expanding access to biological treatments for chronic inflammatory conditions. The biosimilar, developed by Samsung Bioepis Co., Ltd. and commercialized by Sandoz, received FDA approval for treating various autoimmune diseases.
The launch represents a crucial step in addressing the needs of approximately 12 million patients affected by conditions such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. This development aligns with Sandoz's strategic goal to become the leading biosimilar provider in the US market.
Clinical Applications and Patient Benefits
Pyzchiva works by targeting IL-12 and IL-23 cytokines, which play a crucial role in inflammatory processes. The biosimilar has been approved for multiple indications, including:
- Moderate to severe plaque psoriasis in patients 6 years and older
- Active psoriatic arthritis in patients 6 years and older
- Moderately to severely active Crohn's disease in adults
- Moderately to severely active ulcerative colitis in adults
Enhanced Features and Accessibility
The biosimilar offers several advantages over the reference medicine, including:
- Extended stability with re-refrigeration capability
- Complete range of dosing options
- Expected interchangeability status in the first half of 2025
- Comprehensive patient support resources
- Insurance coverage assistance
- Self-injection training
- Co-pay program for commercially insured patients
Expert Perspectives
"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."
Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation, emphasized the significance of this development: "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. Biosimilars offer great potential for putting these effective treatment options within reach of those who may have been previously unable to afford them."
Product Specifications
Pyzchiva is available in multiple formulations:
- 45 mg/0.5 mL pre-filled syringes
- 90 mg/mL pre-filled syringes
- 130 mg/26 mL single-dose vials for intravenous injection
- 45 mg/0.5 mL subcutaneous single-dose vials
This launch follows a settlement and license agreement with Johnson & Johnson for the US market, with Sandoz securing commercialization rights in multiple territories including the US, Canada, European Economic Area, Switzerland, UK, and Brazil.
