Alvotech

FDA approves Alvotech and Teva's SELARSDI 130mg/26mL for ulcerative colitis and Crohn's disease, aligning with Johnson & Johnson's Stelara. SELARSDI targets IL-12 and IL-23 cytokines, expected to launch Q1 2025 in the US.

Alvotech and Teva Pharmaceuticals announce FDA approval of Selardsi (ustekinumab-aekn) for treating adults with moderately severe and severe Crohn’s disease or ulcerative colitis, expanding on Stelara. Selardsi, available in a 130 mg/26mL single dose, will launch in Q1 2025 in the U.S. Dosage varies by patient weight, with subcutaneous maintenance doses of 90mg every eight weeks. Common side effects include nasopharyngitis, injection site erythema, and vulvovaginal candidiasis/mycotic infection in Crohn’s patients, and nasopharyngitis, headache, and abdominal pain in ulcerative colitis patients.

FDA approved SELARSDI 130 mg/26 mL for intravenous infusion, expanding its use to treat Crohn’s disease and ulcerative colitis in adults. SELARSDI, a biosimilar to Stelara®, is expected to launch in the U.S. in Q1 2025, following its approval for other forms and indications in 2024.

The FDA has approved an additional presentation of ustekinumab-aekn (Selarsdi; Alvotech, Teva), expanding its label to include treatment of adults with Crohn disease (CD) and ulcerative colitis (UC). This new 130 mg/26 mL solution in a single-dose vial for intravenous infusion aligns with the reference product's indications and is expected to launch in the US in early 2025.

FDA approves Stelara biosimilar Selarsdi for Crohn’s disease and ulcerative colitis, expected in U.S. early 2025.

FDA approves SELARSDI 130 mg/26 mL for IV infusion, expanding its label to treat Crohn's disease and ulcerative colitis in adults. Previously approved SELARSDI 45 mg/0.5 mL and 90 mg/mL for subcutaneous use in April 2024. U.S. launch expected in Q1 2025.

Teva and Alvotech announce FDA expanded labeling for their biosimilar of J&J's Stelara to include treatment of Crohn's disease and ulcerative colitis.

Alvotech and Teva Pharmaceuticals announce FDA approval of SELARSDI, 130 mg/26 mL solution in a single-dose vial for intravenous infusion, aligning its label with Stelara's indications in the U.S. at launch in Q1 2025.

FDA approves SELARSDI (ustekinumab-aekn) 130 mg/26 mL for IV infusion, aligning with Stelara's indications in the U.S. by Q1 2025. SELARSDI 45 mg/0.5 mL and 90 mg/mL injections for subcutaneous use were approved in April 2024 for treating moderate to severe plaque psoriasis and active psoriatic arthritis. Alvotech and Teva's partnership includes nine products, with SELARSDI and SIMLANDI (adalimumab-ryvk) as biosimilars to Stelara and Humira, respectively.