FDA approves Selardsi (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara (ustekinumab). Teva Pharma + Alvotech

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.  and Alvotech announced that the FDA  has approved Selardsi (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara (ustekinumab). As of April 30, 2025, Selardsi is available and interchangeable in all presentations matching the reference product, including the treatment of adults and pediatric psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis.

“The FDA’s confirmation of full interchangeability for Selardsi is an important development for patients and providers seeking to expand access to this important treatment,” said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. “Teva’s recent launch of two biosimilars – Selardsi 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.”

“Interchangeability of Selardsi with Stelara will further enable increased access for U.S. 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,” said Anil Okay, Chief Commercial Officer for Alvotech. “With two important biosimilars on the U.S. 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.”

Approved presentations of Selardsi are 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection, 45 mg/0.5 mL in a single-dose vial for subcutaneous injection and 130 mg/26 mL in a single-dose vial for intravenous infusion.

Ustekinumab is a human monoclonal antibody (mAb) 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 and psoriatic arthritis, and inflammatory diseases like Crohn’s disease and ulcerative colitis[1]. Alvotech developed and produces selar 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 Stelara.

In August 2020, Teva and Alvotech entered into a strategic partnership for the exclusive commercialization of five Alvotech biosimilar product candidates, and in July 2023, the partnership was extended to include two additional biosimilars and new presentations of two previously partnered products. Alvotech manages development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., leveraging its experience and extensive sales and marketing infrastructure.