FDA Grants Ustekinumab-Aekn Interchangeability Designation for Stelara
Selarsdi is interchangeable for all indications of ustekinumab, including treatment of psoriatic arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis.
The FDA approved ustekinumab-aekn (Selarsdi) as an interchangeable biosimilar with ustekinumab (Stelara). The product is currently available and interchangeable for all indications of ustekinumab, including treatment of psoriatic arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis. The interchangeability designation comes after the expiration of exclusivity for the first interchangeable biosimilar, ustekinumab-auub (Wezlana), on April 30, 2025.1-3
Selarsdi is interchangeable for all indications of ustekinumab, including treatment of psoriatic arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis. | Image Credit: sunnychicka - stock.adobe.com
Interchangeability designation allows pharmacists to substitute a biosimilar for a reference product at the pharmacy level and without a provider’s approval, aiming to increase access and affordability to specialty high-cost medications.
“Interchangeability of Selarsdi with Stelara will further enable increased access for US patients to more affordable treatment options and contribute to lowering health care costs, which is an important part of our mission as a leading developer and manufacturer of biosimilars globally,” Anil Okay, chief commercial officer for Alvotech, said in a news release.1 “With 2 important biosimilars on the US market and biologics license applications for 3 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.”
Ustekinumab-aekn is available in 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringes for subcutaneous injection as well as vials in the 45 mg/0.5 mL strength for subcutaneous injection and 130 mg/26 mL for intravenous infusion. The biosimilar became available in the US in February 2025.2
The FDA approved ustekinumab-aekn to treat moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children 6 years and older in April 2024. Ustekinumab is a monoclonal antibody that targets p40 protein, a component of IL-12 and IL-23, which plays a large role in the treatment of immune-mediated diseases. The approval was based on clinical data from 2 studies: the AVT04-GL-301 study (NCT04930042) and the ATV04-GL-101 study (NCT04744363).4
In August 2020, Teva and Alvotech entered a strategic partnership for the commercialization of 5 Alvotech biosimilar candidates, with the partnership being extended to 2 additional biosimilars and new presentations of 2 previous products in July 2023. The first biosimilar from the partnership was adalimumab-ryvk (Simlandi), referencing adalimumab (Humira), which was approved in February 2024 and launched in May 2024. Three additional biosimilar candidates have been accepted for review by the FDA, and they include AVT05, a proposed biosimilar for golimumab (Simponi; Simponi Aria), and AVT06, a proposed biosimilar for aflibercept (Eylea). The goal dates for approval are expected in quarter 4 of 2024, according to the news release.1
“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,” Thomas Rainey, senior vice president of US Biosimilars at Teva, said in the news release.1
READ MORE: Biosimilar Resource Center
Ready to impress your pharmacy colleagues with the latest drug information, industry trends, and patient care tips? Sign up today for our free Drug Topics newsletter.
