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 originally approved Otulfi as a biosimilar in October 2024 based on clinical data that demonstrated the product was highly similar to Stelara.

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 ...

while Imaavy is given as an intravenous infusion every two weeks. J&J has set a list price of $12,480 per vial for its drug, saying that it is "competitively priced" compared to the other FcRn ...

Extensive analytical characterization between Starjemza and US and EU Stelara was conducted on structural, physicochemical, and biological properties to support bio-similarity of Starjemza. A ...

Original Medicare provides coverage for IV infusion therapy when a doctor determines it to be medically necessary, both in a clinic setting and at home. Medicare Advantage (Part C) plans need to ...