Teva Pharmaceuticals and Alvotech have announced that the US Food and Drug Administration (FDA) has approved the Selarsdi (ustekinumab-aekn) injection as interchangeable with reference biologic Stelara (ustekinumab).
As of 30 April, Selarsdi is now available and interchangeable in all presentations that correspond with Stelara, including the treatment for both adult and pediatric patients with psoriatic arthritis, plaque psoriasis, ulcerative colitis, and Crohn’s disease.
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Selarsdi’s approved presentations include a subcutaneous injection with 45mg/0.5ml and 90mg/ml in a single-dose prefilled syringe, as well as 45mg/0.5ml in a single-dose vial.
The approved presentation is also for intravenous infusion with 130mg/26ml in a single-dose vial.
Teva Pharmaceuticals US biosimilars senior vice-president Thomas Rainey said: “The FDA’s confirmation of full interchangeability for Selarsdi is an important development for patients and providers seeking to expand access to this important treatment.
“Teva’s recent launch of two biosimilars – Selarsdi and Epysqli – coupled with a rich pipeline of assets expected to launch over the next few years, position Teva to establish a strong leadership position in the growing landscape of biosimilars and to drive growth for the company as it embarks on the next phase of its strategy.”
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By GlobalDataUstekinumab, the active component in Selarsdi, is a human monoclonal antibody (mAb) that targets the p40 protein.
This protein is a shared component of interleukin (IL)-12 and IL-23 cytokines, which are critical in treating immune-mediated conditions such as psoriasis and psoriatic arthritis, as well as inflammatory conditions such as ulcerative colitis and Crohn’s disease.
Alvotech developed and produces Selarsdi, leveraging Sp2/0 cells and a continuous perfusion method. The injection has been approved as Selarsdi in the US and introduced under various names in different regions, including Jamteki in Canada, Uzpruvo in Europe, and Ustekinumab BS (F) in Japan.
Applications are being reviewed in several nations worldwide.
The strategic partnership between the companies, initiated in August 2020, was established for the exclusive commercialisation of five biosimilar product candidates of Alvotech.
In July 2023, the collaboration expanded to include two additional biosimilars and new presentations of two previously collaborated products.
Including Selarsdi, the companies have seen two biosimilars developed by them gain US regulatory approval with interchangeability.
Alvotech and Teva noted that they have three additional biosimilar candidates under review by the US regulator: a proposed biosimilar for Simponi (golimumab) and Simponi Aria (golimumab), AVT05, and AVT06, which is a proposed biosimilar for Eylea (aflibercept).
