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FDA Approves New Intravenous Formulation of Ustekinumab Biosimilar SELARSDI™

• The FDA has approved a new intravenous formulation of SELARSDI™ (ustekinumab-aekn), a biosimilar to STELARA® (ustekinumab), expanding its potential use. • This new presentation of SELARSDI™, a 130 mg/26 mL single-dose vial for intravenous infusion, complements the existing subcutaneous injection formulations. • The approval allows SELARSDI™ to align its label with STELARA®, potentially benefiting patients with gastrointestinal diseases as the U.S. launch approaches in early 2025.

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.
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Reference News

[1]
Alvotech and Teva Announce FDA Approval of Additional Presentation for Ustekinumab Biosimilar
jdsupra.com · Oct 31, 2024

Alvotech and Teva announced FDA approval for a new 130 mg/26 mL (5 mg/mL) SELARSDI™ presentation, expanding its label to...

[2]
Alvotech and Teva Announce FDA Approval of Additional ...
goodwinlaw.com · Oct 31, 2024

On October 22, 2024, Alvotech and Teva announced FDA approval for a new SELARSDI (ustekinumab-aekn) presentation, 130 mg...

[3]
Alvotech and Teva Announce FDA Approval of Additional ...
bigmoleculewatch.com · Oct 31, 2024

Alvotech and Teva announced FDA approval for SELARSDI™ (ustekinumab-aekn) in a new 130 mg/26 mL IV infusion format, expa...

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