Ustekinumab-aekn (Selarsdi) is now approved for all indications of the reference product, including moderate to severe plaque psoriasis and active psoriatic arthritis in adult and pediatric patients aged 6 years and older, as well as moderately to severely active Crohn’s disease and ulcerative colitis in adult patients. Interchangeability applies to all approved formulations, including subcutaneous and intravenous presentations.
The ustekinumab biosimilar is a human monoclonal antibody that targets the p40 subunit shared by interleukin (IL)-12 and IL-23. It's produced using Sp2/0 cells and a continuous perfusion process, aligning with the manufacturing approach for the reference biologic. The U.S. Food and Drug Administration (FDA) approved the ustekinumab biosimilar as interchangeable with the reference biologic ustekinumab (Stelara) in all matching presentations, allowing broader access across approved indications.
The approval is part of a strategic partnership between Alvotech and Teva Pharmaceuticals, established in 2020 and expanded in 2023, which aims to commercialize multiple biosimilars in the United States. The ustekinumab biosimilar is the second interchangeable biosimilar from this collaboration to receive FDA approval, following adalimumab-ryvk (Simlandi), approved in February 2024 as a biosimilar to adalimumab (Humira). Three additional Biologics License Applications—AVT05 (a proposed biosimilar to golimumab [Simponi and Simponi Aria]) and AVT06 (a proposed biosimilar to aflibercept [Eylea])—are currently under FDA review with target decision dates in the fourth quarter of 2025.
The safety profile of the ustekinumab biosimilar is consistent with the reference biologic ustekinumab and includes risks for serious infections, including bacterial, fungal, viral, and mycobacterial etiologies; hypersensitivity reactions; and malignancy. Adverse events observed in clinical trials included nasopharyngitis, headache, upper respiratory infections, and gastrointestinal disturbances. Clinicians are advised to evaluate patients for tuberculosis prior to initiating therapy, avoid use in patients with clinically significant infections, and monitor for posterior reversible encephalopathy syndrome and other serious adverse reactions. The ustekinumab biosimilar is contraindicated in patients with known hypersensitivity to ustekinumab or its excipients.
Source: Teva Pharmaceuticals