Alvotech

The FDA approved an additional presentation of Alotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn), a biosimilar to Stelara (ustekinumab), for intravenous infusion. This approval aligns Selarsdi's label with Stelara's indications, including psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn disease. This marks the second biosimilar of Stelara approved by the FDA, following earlier approvals of Wezlana, Pyzchiva, and Otulfi.

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 injection in April 2024. U.S. launch expected in Q1 2025.

Alvotech and Teva announce FDA approval of Selarsdi (ustekinumab-aekn) in a new 130 mg/26 mL presentation, expanding its label to align with Stelara® (ustekinumab) indications. The U.S. launch is expected in Q1 2025, following successful biosimilar ustekinumab launches in Canada, Japan, and Europe.

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

FDA approves 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.

Alvotech and Teva announced FDA approval for SELARSDI™ (ustekinumab-aekn) in a new 130 mg/26 mL presentation, expanding its label to include Crohn’s disease and ulcerative colitis treatments. SELARSDI aligns with Stelara®'s indications, with a U.S. launch expected in Q1 2025. This follows previous approvals for psoriasis and psoriatic arthritis treatments.

FDA approves Imuldosa (ustekinumab-srlf), a biosimilar to Stelara, for treating psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis in both adults and pediatric patients. Imuldosa, initially developed as DMB-3115, demonstrated similar pharmacokinetic, safety, tolerability, and efficacy profiles to Stelara, adhering to FDA biosimilar guidance. This marks the fifth FDA approval for an ustekinumab product, with Imuldosa anticipated to launch in the first half of 2025.

Eli Lilly's Omvoh showed better histologic response vs. J&J's Stelara in Crohn's disease patients after 52 weeks, with safety consistent with known profile. Lilly aims to expand Omvoh's label and therapeutic potential in inflammatory bowel diseases, potentially challenging Stelara's market dominance.

Dong-A ST received FDA approval for Imuldosa, a Stelara biosimilar, amidst a crowded market of approved but unlaunched biosimilars. Stelara's sales are expected to decline post-2023 patent expiry, with biosimilars like Amgen's Wezlana and Samsung Bioepis's Pyzchiva set to launch in 2025. Stelara, an IL-12/IL-23 inhibitor, treats psoriatic arthritis, Crohn’s disease, plaque psoriasis, and ulcerative colitis.