The U.S. FDA has approved Teva Pharmaceuticals and Alvotech’s Selarsdi injection, a biosimilar to Stelara (ustekinumab), as an interchangeable treatment for inflammatory conditions.
The approval grants Selarsdi the same indications as the reference biologic, including treatment for psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ulcerative colitis. Approved presentations of Selarsdi are 45mg/0.5mL and 90mg/mL in a single-dose prefilled syringe for subcutaneous injection, 45mg/0.5mL in a single-dose vial for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion.
As of April 30, Selarsdi will be available in all presentations that match the reference product.
Interchangeable with Stelara
In February, the FDA provisionally determined that Selarsdi will be interchangeable with the reference biologic Stelara, following the expiration of exclusivity for the first interchangeable biosimilar, on April 30, 2025.
“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,” says Thomas Rainey, Senior Vice President, U.S. Biosimilars, at Teva, in a news release. “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.”
“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,” adds 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.”
Under the partnership, Alvotech is responsible for the development and manufacturing of Selarsdi, while Teva handles commercialization in the U.S. market.
Two biosimilars developed under the Teva – Alvotech partnership have now been granted FDA approval with interchangeability, including Selarsdi. In February 2024, the FDA approved Simlandi (adalimumab-ryvk), the first high-concentration, citrate-free interchangeable biosimilar to Humira (adaliumumab), which was launched in the U.S. in May 2024.
