FDA Approves Alvotech/Teva's Ustekinumab Biosimilar, SELARSDI
核心洞察
The FDA has approved SELARSDI (搜索) (ustekinumab-aekn), a biosimilar to Johnson & Johnson’s STELARA® (ustekinumab), for treating moderate to severe plaque psoriasis (搜索) and active psoriatic arthritis (搜索).
SELARSDI (搜索), developed by Alvotech and to be commercialized by Teva (搜索) in the U.S., is administered as a subcutaneous injection for adult and pediatric patients aged six years and older.
This marks the second ustekinumab biosimilar approved by the FDA, following Amgen’s WEZLANA, and Alvotech and Teva (搜索) settled with Johnson & Johnson to market it no later than February 21, 2025.
Alvotech and Teva (搜索) Pharmaceutical Industries have received FDA approval for SELARSDI (搜索) (ustekinumab-aekn), a biosimilar to Johnson & Johnson’s STELARA® (ustekinumab). The approval, announced on April 16, 2024, covers the treatment of moderate to severe plaque psoriasis (搜索) and active psoriatic arthritis (搜索) in adult and pediatric patients aged six years and older. SELARSDI will be administered as a subcutaneous injection.
SELARSDI (搜索) represents the second ustekinumab biosimilar to gain FDA approval, following Amgen’s WEZLANA (ustekinumab-auub), which was approved in October 2023. Ustekinumab is a human monoclonal antibody that targets the p40 subunit shared by interleukin (IL)-12 and IL-23 (搜索), cytokines implicated in inflammatory and autoimmune diseases.
The development and commercialization agreement between Alvotech and Teva (搜索) includes a settlement with Johnson & Johnson reached in June 2023. This agreement allows Alvotech and Teva to market their ustekinumab biosimilar in the United States no later than February 21, 2025. The introduction of biosimilars like SELARSDI (搜索) aims to provide more affordable treatment options for patients suffering from psoriasis and psoriatic arthritis (搜索), potentially increasing access to these therapies.
Psoriasis is a chronic autoimmune disease affecting approximately 2-3% of the world's population. Psoriatic arthritis (搜索), a related inflammatory condition, affects up to 30% of individuals with psoriasis. These conditions can significantly impact patients' quality of life, leading to physical discomfort, psychological distress, and socioeconomic burden. Current treatment options include topical corticosteroids, phototherapy, conventional systemic therapies, and biologic agents like ustekinumab. Biosimilars offer a cost-effective alternative to originator biologics, potentially reducing healthcare costs and expanding treatment access for patients in need.