Teva, Alvotech get expanded FDA approval for Stelara biosimilar

Teva Pharmaceutical Industries (NYSE:TEVA) and Alvotech (NASDAQ:ALVO) said the FDA has expanded labeling for its biosimilar of Johnson & Johnson’s (JNJ) Stelara to include the treatment of Crohn’s disease and ulcerative colitis.

The companies said the FDA approved a 130mg/26mL single dose vial of the product for intravenous infusion, which should further align the label of its biosimilar Selarsdi with Stelara’s indications.

In April, the FDA approved 45mg/0.5mL and 90mg/mL single-dose prefilled syringes of Selarsdi for subcutaneous injection for the treatment of plaque psoriasis and psoriatic arthritis.

The product is expected to be launched in the U.S. for all indications in Q1 2025, according to a statement.

Teva and Alvotech launched a biosimilar of Humira in the U.S. in May.