FDA Approves Stelara Biosimilar Selardsi for Additional Indications

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Alvotech and Teva Pharmaceuticals announced this week the FDA approval of Selardsi (ustekinumab-aekn) to treat adults with moderately severe and severe Crohn’s disease or ulcerative colitis, according to a news release. This approval is an expansion on the reference product Stelara and is expected to launch in the first quarter of 2025 in the United States.

Selardsi will be available in a 130 mg/26mL single dose and will be administered intravenously. Dosage is dependent on weight. If the patient weighs 121 pounds or less, they will be given two vials. Patients weighing between 121 pounds and 187 pounds should take three vials. Patients weighing more than 187 pounds should be given four vials. Subcutaneous maintenance doses of 90mg should be given every eight weeks after the initial intravenous dose.

Crohn’s disease and ulcerative colitis are both autoimmune diseases that cause chronic inflammation in the digestive tract. Ulcerative colitis affects only the colon and rectum whereas Crohn’s disease can cause inflammation in any part of the digestive tract, from mouth to anus. Shared symptoms include stomach cramping, diarrhea, weight loss, fatigue and rectal bleeding.

Ustekinumab works by targeting the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which treat immune related diseases such as psoriasis, ulcerative colitis and Crohn’s disease.

The most common side effects of Selardsi in Crohn’s patients receiving a maintenance dose were nasopharyngitis, injection site erythema and vulvovaginal candidiasis/mycotic infection, which occurred in at least 3% of patients.

The most common side effects in ulcerative colitis patients receiving a maintenance dose were nasopharyngitis, headache and abdominal pain, occurring in at least 3% of patients.

There are five Stelara biosimilars. The latest, Selardsi, was approved by the FDA in April 2024 as a 45 mg/0.5 mL and 90 mg/mL injection in a prefilled syringe for subcutaneous use for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients six years and older.

“We welcome this step which is fully in line with our plan to align the Selardsi label with the indications of the reference product, prior to launch next year,” Robert Wessman, Chairman and CEO of Alvotech said in the news release. “We are looking forward to the U.S. launch, after very successful launches of the first biosimilar ustekinumab in Canada, Japan and Europe.”