Sandoz Launches First Ustekinumab Biosimilar Autoinjector in Europe with Pyzchiva
核心洞察
Sandoz has launched Pyzchiva (ustekinumab) as the first ustekinumab biosimilar autoinjector commercially available in Europe, developed by Samsung Bioepis (搜索).
The biosimilar is approved to treat multiple chronic inflammatory conditions including plaque psoriasis (搜索), psoriatic arthritis (搜索), Crohn's disease (搜索), and pediatric plaque psoriasis in patients aged six and older.
The autoinjector features automatic dosing, reduced injection pain, compact design, and flexible storage options to potentially improve treatment adherence for chronic inflammatory diseases.
Sandoz has achieved a significant milestone in European biosimilar access by launching Pyzchiva® (ustekinumab) in autoinjector form, marking the first ustekinumab biosimilar autoinjector to become commercially available in the region. The launch represents a strategic advancement for patients managing chronic inflammatory diseases across Europe.
Advanced Autoinjector Technology Addresses Patient Needs
The Pyzchiva® autoinjector incorporates several patient-centric features designed to improve treatment adherence and patient experience. The device offers automatic dosing capabilities, reduced injection pain, a compact design for portability, and flexible storage options. These features address critical real-world challenges faced by patients managing chronic inflammatory conditions that require long-term treatment regimens.
"Access to medicine does not end when it reaches the hands of the patient," said Christophe Delenta, President Europe, Sandoz. "The Pyzchiva® autoinjector, with its thoughtful and advanced features, addresses the real-world needs of patients in managing chronic inflammatory diseases."
Comprehensive Treatment Coverage for Multiple Indications
Developed by Samsung Bioepis (搜索), Pyzchiva® has received approval for treating multiple chronic inflammatory conditions in European patients. The biosimilar is indicated for adults with plaque psoriasis (搜索), psoriatic arthritis (搜索), and Crohn's disease (搜索), as well as pediatric plaque psoriasis in patients aged six years and older weighing over 60 kilograms.
The biosimilar is available in multiple formulations to accommodate different treatment protocols: a 130 mg concentrate in a vial for solution for infusion, and both 90 mg and 45 mg concentrate solutions for injection in pre-filled syringes. Notably, Pyzchiva® is the first ustekinumab biosimilar in Europe to launch with all reference medicine strengths, including the 130mg vial initiation dose specifically for Crohn's disease (搜索) treatment.
Addressing Significant Disease Burden in Europe
The launch addresses a substantial unmet need across European healthcare systems. Europe has the highest prevalence of psoriasis (搜索) worldwide, affecting an estimated 6.4 million people and significantly impacting patients' quality of life. Plaque psoriasis (搜索) represents the most common form of the disease, affecting 85% to 90% of patients with psoriasis.
Given the high prevalence of inflammatory diseases such as psoriasis (搜索) and Crohn's disease (搜索) in Europe, ensuring patient adherence to treatment regimens is crucial for reducing disease flares and associated healthcare costs. The improved delivery mechanism offered by the autoinjector may contribute to better long-term treatment outcomes.
Strategic Partnership and Market Expansion
Sandoz entered into a development and commercialization agreement with Samsung Bioepis (搜索) in September 2023, securing rights to market Pyzchiva® in the United States, Canada, the European Economic Area, Switzerland, and the United Kingdom. Under this partnership structure, Samsung Bioepis maintains responsibility for development, registration, intellectual property management, manufacturing, and supply chain operations.
The biosimilar has already launched in 23 European markets, with the autoinjector formulation now available in Spain. This expansion strengthens Sandoz's established immunology portfolio in Europe, bringing the company's total to five biosimilars marketed in this therapeutic area.
Biosimilar Equivalency and Safety Profile
Pyzchiva® has been developed as a biosimilar demonstrating equivalent efficacy and comparable safety to the reference medicine Stelara®, a human monoclonal antibody targeting interleukin (IL)-12/23. The biosimilar underwent rigorous development and regulatory review processes to ensure it meets the same standards for quality, safety, and efficacy as the original biologic therapy.
Rebecca Guntern, President Europe, Sandoz, emphasized the broader healthcare impact: "Timely and expanded access to safe, effective and affordable medicines can improve quality of life for millions of people living with chronic inflammatory diseases. Pyzchiva is one of the first ustekinumab biosimilars in Europe, which marks a significant milestone on that road."