FDA Approves Teva and Alvotech’s SELARSDI As Interchangeable Biosimilar To Stelara For Inflammatory Diseases

Teva Pharmaceuticals and Alvotech have announced that the FDA has approved SELARSDI™ (ustekinumab-aekn) as an interchangeable biosimilar to Stelara® (ustekinumab), expanding treatment options for immune-mediated diseases. SELARSDI is now available in all corresponding presentations for conditions including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. These include prefilled syringes and vials for subcutaneous injection and an intravenous infusion option.

“Interchangeability of SELARSDI 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.”

SELARSDI is a biosimilar of ustekinumab, a monoclonal antibody that targets the p40 subunit shared by interleukin-12 and interleukin-23, which are implicated in several chronic inflammatory conditions. Alvotech developed SELARSDI using the same host cell line and continuous perfusion manufacturing process as Stelara®, supporting its approval as an interchangeable biosimilar. This milestone marks the second interchangeable biosimilar approved under Teva and Alvotech’s strategic partnership.

“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,” said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva.

The Teva-Alvotech alliance, initiated in 2020 and expanded in 2023, has now produced two FDA-approved interchangeable biosimilars, SELARSDI and SIMLANDI® (adalimumab-ryvk), the latter being a high-concentration alternative to Humira®. Additional biosimilars developed by Alvotech for Simponi® and Eylea® are under FDA review, with approval decisions expected in late 2025. Teva handles U.S. commercialisation while Alvotech leads development and manufacturing.