FDA Approves New IV Formulation of Selarsdi (ustekinumab-aekn) for Expanded Indications
Key Insights
The FDA has approved a new intravenous formulation of Selarsdi (search) (ustekinumab-aekn), a biosimilar to Stelara, expanding its potential uses.
This approval aligns Selarsdi (search)'s label more closely with Stelara's indications in the U.S., including use for gastrointestinal diseases.
The U.S. launch of Selarsdi (search) is anticipated in the first quarter of 2025, increasing patient access to ustekinumab biosimilars.
The Food and Drug Administration (FDA) has granted approval for a new presentation of Selarsdi (search) (ustekinumab-aekn), a biosimilar to Stelara (ustekinumab), in a 130 mg/26 ml (5 mg/ml) solution within a single-dose vial designed for intravenous infusion. This approval, announced by Alvotech and Teva (search) Pharmaceutical, is a strategic move to align Selarsdi's label with the reference product, Stelara, particularly regarding indications for gastrointestinal diseases. The U.S. launch is expected in early 2025.
Strategic Alignment and Expanded Access
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, underscoring the company's commitment to increasing the availability of biosimilars for patients globally.
Thomas Rainey, senior vice president of 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 emphasizes its dedication to increasing the uptake of biosimilars and its ongoing partnership with Alvotech, which now encompasses a portfolio of nine products.
Background and Previous Approvals
In April 2024, the FDA approved Selarsdi (search) in 45 mg/0.5 ml and 90 mg/ml injection formats within prefilled syringes for subcutaneous use. These formulations are indicated for treating moderate to severe plaque psoriasis (search) and active psoriatic arthritis (search) in both adult and pediatric patients aged six years and older. Alvotech and Teva (search) reached a settlement and license agreement in June 2023 with the manufacturer of the reference biologic, setting a license entry date for Selarsdi in the United States no later than February 21, 2025.
Mechanism of Action
Ustekinumab is a human monoclonal antibody that selectively targets the p40 protein (search), a component common to both interleukin (IL)-12 and IL-23 (search) cytokines. These cytokines play critical roles in immune-mediated diseases such as psoriasis, psoriatic arthritis (search), ulcerative colitis (search), and Crohn’s disease (search). By blocking the activity of IL-12 (search) and IL-23, ustekinumab helps to reduce inflammation and alleviate symptoms associated with these conditions.
Partnership and Future Prospects
Alvotech and Teva (search) entered a strategic partnership in August 2020 for the exclusive commercialization of several Alvotech biosimilar product candidates, including Selarsdi (search). Under this agreement, Alvotech is responsible for the development and manufacturing of the biosimilars, while Teva manages their commercialization within the United States. This collaboration aims to broaden patient access to more affordable biologic therapies.