Stelara comes as a liquid solution given as an injection under the skin or an intravenous (IV) infusion. Stelara contains the drug ustekinumab, which is a biologic medication. A biologic ...

Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), in a ...

The FDA approved the Stelara biosimilar, Selarsdi, as a 130 mg/26 mL single-dose IV infusion for adult patients with Crohn’s disease and ulcerative colitis, Alvotech and Teva Pharmaceuticals ...

The approved presentation is also for intravenous infusion with 130mg/26ml ... "FDA approves Selarsdi injection as interchangeable with Stelara" was originally created and published by ...

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.

It is available in both subcutaneous injection and intravenous infusion ... at an 85% discount to the current WAC list price of Stelara to help improve patient access to high-quality biologic ...

Ustekinumab-stba is approved for multiple conditions, showing comparable efficacy and safety to Stelara in clinical trials. The biosimilar will be available in subcutaneous and intravenous forms ...

The Food and Drug Administration has approved Celltrion's Steqeyma (ustekinumab-stba), a biosimilar to Johnson & Johnson's Stelara (ustekinumab), for subcutaneous injection or intravenous infusion ...

The Food and Drug Administration (FDA) has approved Imuldosa ™ (ustekinumab-srlf), a biosimilar to Stelara ® (ustekinumab ... single-dose vial for intravenous infusion. The product is expected ...

Vigorous protection of Stelara’s position in the immunology ... of administration as a favourable option for patients over intravenous or subcutaneous biologics. His reference to the therapy ...

Patients may now switch between Otulfi and Stelara without requiring a prescription ... and a 130mg/26mL single-dose vial for intravenous infusion. “Fresenius Kabi is pleased to receive this ...

Celltrion’s Stelara biosimilar ustekinumab-stba (Steqeyma ... subcutaneous injection and a 130 mg/26 mL single-dose vial for intravenous infusion. By February 2025, Celltrion plans to initiate ...