The FDA has granted approval for a new formulation of SELARSDI™ (ustekinumab-aekn), a biosimilar to STELARA® (ustekinumab), offering a new intravenous delivery option. This approval, announced on October 22, 2024, by Alvotech and Teva, expands the therapeutic potential of SELARSDI™ by aligning its indications more closely with those of the reference product, STELARA®. The new formulation is presented as a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial designed for intravenous infusion.
This approval supplements the previously approved subcutaneous injection formulations of SELARSDI™, available in 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringes. With this expanded presentation, SELARSDI™ is poised to address a broader range of patient needs, particularly in gastrointestinal diseases.
Clinical Significance
The introduction of an intravenous formulation of ustekinumab-aekn is particularly relevant for patients requiring intravenous administration, potentially offering an alternative for those who may not be suitable candidates for subcutaneous injections. Ustekinumab, a human monoclonal antibody, targets the p40 subunit shared by interleukin-12 (IL-12) and interleukin-23 (IL-23), cytokines implicated in inflammatory and autoimmune disorders. STELARA® is approved for the treatment of several conditions, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Commercialization and Market Impact
According to Thomas Rainey, Senior Vice President, U.S. Biosimilars, this approval enables the company to serve patients battling gastrointestinal diseases as the U.S. launch of SELARSDI approaches in early 2025. The biosimilar market is growing, and the availability of SELARSDI™ offers a cost-effective alternative to STELARA®, potentially increasing patient access to this important medication. The launch of SELARSDI™ in the U.S. is anticipated to have a significant impact on the treatment landscape for inflammatory conditions, providing both clinicians and patients with a valuable new option.