The U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) in a new presentation, 130mg/26mL (5mg/mL) solution in a single-dose vial for intravenous infusion.
This approval paves the way for SELARSDI to further align its label with the indications of the reference product Stelara (ustekinumab) in the U.S. at launch, which is expected in the first quarter of 2025.
Ustekinumab is a human monoclonal antibody that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated diseases like psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease.
In April 2024, the FDA approved SELARSDI 45mg/0.5mL and 90mg/mL injection in a prefilled syringe for subcutaneous use, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients aged 6 and older. In June 2023, Alvotech and Teva announced that they had reached a settlement and license agreement with the manufacturer of the reference biologic, granting a license entry date for SELARSDI in the United States no later than February 21, 2025.
Alvotech developed and produces SELARSDI using Sp2/0 cells and a continuous perfusion process, which are the same type of host cell line and process used in the production of the reference product Stelara.
“We welcome this step which is fully in line with our plan to align the SELARSDI label with the indications of the reference product, prior to launch next year,” says Robert Wessman, Chairman and CEO of Alvotech, in a news release. “We are looking forward to the U.S. launch, after very successful launches 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.”
“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.,” adds Thomas Rainey, Senior Vice President, U.S. Biosimilars. “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.”
In August 2020, Alvotech and Teva entered into a strategic partnership for the exclusive commercialization of five of Alvotech’s biosimilar product candidates, including SELARSDI. The partnership has since expanded and now includes a total of nine products. Alvotech handles development and manufacturing using its purpose-built end-to-end platform, while Teva is responsible for commercialization in the U.S., which leverages Teva’s experience and extensive sales and marketing infrastructure. Two biosimilars developed under the partnership have been given FDA approval: SELARSDI, and in February 2024, the FDA approved SIMLANDI (adalimumab-ryvk), the first high-concentration, citrate-free interchangeable biosimilar to Humira (adalimumab). SIMLANDI was launched in the U.S. in May 2024.
