FDA Approves New IV Infusion Presentation of Selarsdi (ustekinumab-aekn) Biosimilar
Key Insights
The FDA has approved a new intravenous infusion formulation of Selarsdi (search) (ustekinumab-aekn), a biosimilar to Stelara, expanding its potential use.
This approval aligns Selarsdi (search)'s label more closely with Stelara's indications, including Crohn's disease and ulcerative colitis (search), ahead of its U.S. launch.
Selarsdi (search), developed by Alvotech and commercialized by Teva (search), is expected to be available in the U.S. in early 2025, increasing patient access.
The FDA has approved a new presentation of Selarsdi (search) (ustekinumab-aekn), a biosimilar to Stelara (ustekinumab), in a 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion. This approval, announced by Alvotech and Teva (search) Pharmaceuticals, expands Selarsdi's potential use and aligns its label with the indications of the reference product, Stelara, particularly in treating gastrointestinal diseases. The U.S. launch is anticipated in the first quarter of 2025.
Expanding Access to Ustekinumab
Robert Wessman, Chairman and CEO of Alvotech, stated, "We welcome this step which is fully in line with our plan to align the Selarsdi (search) label with the indications of the reference product, prior to launch next year." He also highlighted the successful launches of the first ustekinumab biosimilar in Canada, Japan, and Europe, emphasizing the commitment to increasing availability and access to ustekinumab for patients worldwide.
Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva (search), added, "This development allows us to serve patients battling gastrointestinal diseases as the U.S. launch of Selarsdi (search) approaches in early 2025." Teva's dedication to increasing the uptake of biosimilars remains steadfast through its partnership with Alvotech across a portfolio of nine partnered products.
Selarsdi's Indications and Mechanism of Action
Selarsdi (search) is a biosimilar to Stelara (ustekinumab), a human monoclonal antibody that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 (search) cytokines. These cytokines play crucial roles in immune-mediated diseases such as psoriasis, psoriatic arthritis (search), ulcerative colitis (search), and Crohn’s disease (search).
The approved indications for Selarsdi (search) include:
- Treatment of moderate to severe plaque psoriasis in adults and pediatric patients 6 years and older who are candidates for phototherapy or systemic therapy.
- Treatment of active psoriatic arthritis in adults and pediatric patients 6 years and older.
- Treatment of moderately to severely active Crohn's disease in adult patients.
- Treatment of moderately to severely active ulcerative colitis in adult patients.
Development and Manufacturing
Alvotech developed and produces Selarsdi (search) using Sp2/0 cells and a continuous perfusion process, mirroring the host cell line and process used in the production of Stelara. This ensures a high degree of similarity between the biosimilar and the reference product.
Strategic Partnership
Alvotech and Teva (search) entered a strategic partnership in August 2020 for the exclusive commercialization of several Alvotech's biosimilar product candidates. Alvotech handles development and manufacturing, while Teva is responsible for commercialization in the U.S., leveraging its experience and infrastructure. This partnership has already resulted in the FDA approval of SIMLANDI (adalimumab-ryvk), a high-concentration, citrate-free interchangeable biosimilar to Humira (adalimumab).
Safety Information
Selarsdi (search) carries warnings and precautions including the risk of infections, potential for malignancy, hypersensitivity reactions, and posterior reversible encephalopathy syndrome (PRES). Patients should be evaluated for tuberculosis (TB) prior to initiating treatment, and live vaccines should be avoided during treatment with Selarsdi. The most common adverse reactions include nasopharyngitis, upper respiratory tract infection, headache, and fatigue.