Teva Pharmaceuticals and its partner Alvotech have received approval from the US Food and Drug Administration (FDA) for Selarsdi (ustekinumab-aekn) as an interchangeable biosimilar with Stelara (ustekinumab).
This approval allows Selarsdi to be used across all its approved indications, including adult and paediatric psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ulcerative colitis.
Teva 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.”
The FDA-approved forms of Selarsdi include 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection, as well as other vial forms for both subcutaneous and intravenous use.
Ustekinumab functions as a human monoclonal antibody aimed at targeting the p40 protein shared by the interleukin-12 and interleukin-23 cytokines. These cytokines are important in managing immune-mediated and inflammatory diseases.
Selarsdi is produced by Alvotech using Sp2/0 cells and continuous perfusion, mirroring the method used for Stelara.
Alvotech chief commercial officer Anil Okay said: “Interchangeability of SELARSDI with Stelara will further enable increased access for US patients to more affordable treatment options and contribute to lowering healthcare costs, which is an important part of our mission as a leading developer and manufacturer of biosimilars globally.
“With two important biosimilars on the US market and Biologics License Applications for three new biosimilar candidates under FDA review, Alvotech continues to rapidly expand its portfolio of high-quality biologics based on a fully integrated approach to development and manufacturing, coupled with a unique focus on biosimilars.”
In 2020, Teva and Alvotech entered into a collaboration to market five biosimilar candidates exclusively in the US, which was expanded in 2023 to include more products and variations.
Under this collaboration, Alvotech is tasked with development and manufacturing while Teva handles commercialisation through its established sales network.
The partnership has led to FDA approval of two interchangeable biosimilars. These include Selarsdi and SIMLANDI (adalimumab-ryvk), a high-concentration biosimilar to Humira approved in February 2024, with a US launch in May 2024.
The companies have also submitted biologics license applications (BLAs) for three additional biosimilars, which include AVT05, akin to Simponi (golimumab) and Simponi Aria (golimumab), and AVT06, similar to Eylea (aflibercept).
The FDA is expected to review these applications by Q4 2025.
Globally, Selarsdi is marketed under different names, JAMTEKI in Canada, UZPRUVO in Europe, and USTEKINUMAB BS (F) in Japan.
Meanwhile, SIMLANDI has gained approval as a Humira biosimilar in over 50 countries including the US, marketed as SIMLANDI or under private labels like HUKYNDRA in Europe, ADALICIP in Australia, and SIMLANDI in Canada.
