The US Food and Drug Administration (FDA) has approved a new presentation of Alvotech and Teva Pharmaceuticals’ SELARSDI (ustekinumab-aekn), expanding its label to include the treatment of adults with ulcerative colitis and Crohn’s disease.
The approval has been granted for SELARSDI 130mg/26mL (5mg/mL) solution in a single-dose vial for intravenous infusion.
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SELARSDI, a human monoclonal antibody, targets the p40 protein found in interleukin (IL)-12 and IL-23 cytokines – key in immune-mediated diseases.
It is developed and produced by Alvotech using Sp2/0 cells and a continuous perfusion process, mirroring the production of Johnson & Johnson (J&J)’s Stelara.
This marks a significant step for SELARSDI, aligning its indications with those of the reference product Stelara. It is expected to launch in the first quarter of 2025 in the US.
Alvotech chairman and CEO Robert Wessman stated: “We welcome this step which is fully in line with our plan to align the SELARSDI label with the indications of the reference product before launch next year.
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By GlobalData“We are looking forward to the US launch, after very successful launches of the first biosimilar ustekinumab in Canada, Japan and Europe.”
Alvotech and Teva established a strategic partnership in August 2020 to exclusively commercialise five biosimilar product candidates, including SELARSDI.
The collaboration has since grown to encompass nine products, with Alvotech managing development and manufacturing and Teva handling US commercialisation.
In June 2023, the companies reached a settlement with the manufacturer of the reference biologic, setting SELARSDI’s US market entry no later than 21 February 2025.
Two biosimilars have gained FDA approval under the partnership.
In April 2024, the FDA approved SELARSDI for moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children aged six and older.
