FDA Approves Pyzchiva (ustekinumab-ttwe), Biosimilar to Stelara, for Inflammatory Conditions
核心洞察
The FDA has approved Pyzchiva (ustekinumab-ttwe) as a biosimilar to Stelara for treating moderate to severe plaque psoriasis (搜索), psoriatic arthritis (搜索), Crohn’s disease (搜索), and ulcerative colitis (搜索).
Pyzchiva, developed by Samsung Bioepis (搜索) and commercialized by Sandoz, is expected to launch in the U.S. in February 2025, potentially offering a more affordable treatment option.
Clinical studies confirmed Pyzchiva's equivalent efficacy and comparable safety to Stelara, supporting its approval for both adult and pediatric patients with approved indications.
The U.S. Food and Drug Administration (FDA) has approved Pyzchiva (ustekinumab-ttwe), a biosimilar to Janssen Biotech (搜索)'s Stelara (ustekinumab), for the treatment of several inflammatory conditions. Developed by Samsung Bioepis (搜索) and to be commercialized by Sandoz, this approval marks a significant step towards providing more accessible and affordable treatment options for patients.
Pyzchiva is indicated for adult and pediatric patients (6 years and older) with moderate to severe plaque psoriasis (搜索) who are candidates for phototherapy or systemic therapy, patients 6 years and older with active psoriatic arthritis (搜索), adult patients with moderately to severely active Crohn’s disease (搜索), and adult patients with moderately to severely active ulcerative colitis (搜索).
Clinical Equivalence and Safety
The FDA's approval was based on a comprehensive review of clinical data, demonstrating that Pyzchiva has equivalent efficacy and comparable safety to Stelara. These findings support its use across all approved indications of the reference medicine. According to Byoung In Jung, vice president and regulatory affairs team leader at Samsung Bioepis (搜索), biosimilars like Pyzchiva can offer more choice and access to biologic treatments, potentially reducing the financial burden on healthcare systems.
Market Entry and Competition
Sandoz plans to launch Pyzchiva in the U.S. in February 2025, aligning with a settlement and license agreement with Janssen Biotech (搜索) Inc. This launch is expected to be among the first wave of ustekinumab biosimilars to enter the U.S. market. However, Pyzchiva will face competition from other Stelara biosimilars, including those from Alvotech and Teva Pharmaceuticals, and Amgen, also slated for market entry in February 2025.
Addressing Unmet Needs
Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation, emphasized the importance of affordable treatment options for chronic conditions like psoriasis and psoriatic arthritis (搜索). "Having more FDA-approved options can help make appropriate healthcare more affordable," she stated, highlighting that systemic medications like biologics are crucial for managing these conditions.
Mechanism of Action
Pyzchiva (ustekinumab-ttwe) functions as a human interleukin (IL)-12 and IL-23 (搜索) antagonist. It is available in 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion.
Important Safety Information
Serious infections have been reported with ustekinumab products; therefore, treatment should not be initiated during any clinically important active infection. Patients should be evaluated for tuberculosis (TB) prior to initiating treatment, and latent TB should be treated before administering Pyzchiva. The drug may also increase the risk of malignancy. Common adverse reactions include nasopharyngitis, upper respiratory tract infection, headache, and fatigue. The use of live vaccines should be avoided during treatment with Pyzchiva.