FDA Approves Alvotech & Teva’s SELARSDI, A New Single-Dose Vial For Intravenous Infusion

Alvotech and Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd., have announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) in a new formulation of 130 mg/26 mL (5 mg/mL) solution for intravenous infusion in a single-dose vial. This approval aligns SELARSDI’s labeling with the reference drug Stelara® (ustekinumab) ahead of its expected U.S. launch in the first quarter 2025.

“We welcome this step, which is fully in line with our plan to align the SELARSDI label with the reference product's indications before launch next year. We look forward to the U.S. launch after the successful launch of the first biosimilar ustekinumab in Canada, Japan, and Europe. This demonstrates our commitment to increasing availability and access to ustekinumab and other biosimilars in our growing pipeline for patients worldwide,” said Robert Wessman, Chairman and CEO of Alvotech.

Previously, in April 2024, the FDA approved two other dose concentrations of SELARSDI, 45 mg/0.5 mL and 90 mg/L, for subcutaneous use, treating moderate to severe plaque psoriasis and active psoriatic arthritis in both adults and pediatric patients aged six and older. Additionally, Alvotech and Teva reached a settlement in June 2023 with the manufacturer of the reference biologic, setting a license entry date for SELARSDI in the U.S. no later than February 21, 2025.

Thomas Rainey, Senior Vice President of U.S. Biosimilars, said, “We are thrilled with the expansion of SELARSDI's indications, marking another significant milestone in Teva’s commitment to increasing access to biosimilars in the U.S.

He also commented,  “This development allows us to serve patients battling gastrointestinal diseases as the U.S. launch of SELARSDI approaches in early 2025. Teva’s dedication to increasing uptake of biosimilars remains steadfast, and we are proud to continue this partnership with Alvotech across a portfolio of nine partnered products.”

SELARSDI is developed using the same Sp2/0 host cell line and continuous perfusion process as reference product Stelara, with ustekinumab, a human monoclonal antibody targeting the p40 protein found in interleukin (IL)-12 and IL-23 cytokines. These cytokines are critical in treating immune-mediated diseases like psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease. 

Alvotech and Teva first partnered in August 2020 to commercialize five of Alvotech’s biosimilar candidates exclusively, including SELARSDI. This partnership has since grown and expanded to nine products. Alvotech manages development and manufacturing through its specialized platform, while Teva oversees U.S. commercialization using its robust sales and marketing infrastructure. Under this collaboration, two biosimilars have received FDA approval, SELARSDI and SIMLANDI® (adalimumab-ryvk), a high-concentration, a citrate-free biosimilar to Humira®, launched in May 2024 after its FDA approval in February 2024.