Alvotech, Teva obtain FDA nod for new Selarsdi indication
Alvotech and Teva have received clearance from the Food and Drug Administration for Selarsdi (ustekinumab-aekn) in a new presentation, 130 mg/26 ml (5 mg/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 Stelara (ustekinumab) in the United States at launch, which is expected in the first quarter of 2025.
“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,” said Robert Wessman, chairman and CEO of Alvotech. “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.”
[Read more: Teva rolls out generic Nexavar tablets]
“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.,” said Thomas Rainey, senior vice president of 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 April 2024, the FDA approved Selarsdi 45 mg/0.5 ml and 90 mg/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 6 years 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 Feb. 21, 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.
[Read more: Teva launches authorized generic of Victoza]
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, while Teva is responsible for commercialization in the United States.