Ladies and gentlemen, the program is about to begin. At this time, it is my pleasure to turn the program over to your host, Joanna Gajuk. Thank you. Thank you. Thanks, everyone, for joining us. Again, ...

Steqeyma, Celltrion’s Stelara (ustekinumab) biosimilar, won Medsafe approval in New Zealand with all originator uses, marking the country’s first Stelara copycat. (Courtesy of Celltrion) Celltrion ...

INCHEON, South Korea, June 16, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA ® (ustekinumab-stba), a ...

Steqeyma is now supplied as a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection for pediatric patients weighing less than 60kg. The Food and Drug Administration (FDA) has approved a ...

On May 5, 2025, Teva and Alvotech announced that the U.S. Food and Drug Administration (FDA) approved SELARSDI (ustekinumab-aekn) injection as an interchangeable biosimilar to the reference product ...

Patients may now switch between Otulfi and Stelara without requiring a prescription change from a health care provider. The Food and Drug Administration (FDA) has designated Otulfi ® (ustekinumab-aauz ...

Credit: Fresenius Kabi. 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 ...

PARSIPPANY, N.J. and REYKJAVIK, Iceland, May 05, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ...

Amgen is nearly alone among its large drugmaker peers in committing to biosimilar drugs. But its decision has helped bolster revenues at a time when its own branded products are facing pressure from ...

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi, an operating company of Fresenius, announced today that the Centers for Medicare and Medicaid Services (CMS) issued a permanent, product-specific ...