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FDA approves Selarsdi injection as interchangeable with Stelara

Teva Pharmaceuticals and Alvotech have announced that the US Food and Drug Administration (FDA) has approved the Selarsdi (ustekinumab-aekn) injection as interchangeable with reference biologic ...
Nasdaq

Bio-Thera Solutions and Hikma Pharmaceuticals announce FDA approval of STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing STELARA® (ustekinumab) Injection

GUANGZHOU, China and LONDON, May 27, 2025 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets ...
Monthly Prescribing Reference

Otulfi Designated Interchangeable Biosimilar to Stelara

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 ...
Becker's ASC

FDA approves STELARA for Crohn’s disease treatment: 5 notes

The FDA recently approved STELARA, a prescription medication for adults suffering from Crohn’s disease. Here’s what you need to know: 1. STELARA is manufactured by Janssen Biotech. 2. This treatment ...
Seeking Alpha

Bio-Thera Solutions and Hikma Pharmaceuticals announce FDA approval of STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing STELARA® (ustekinumab) Injection

This news release contains certain forward-looking statements relating to STARJEMZA ® /BAT2206 or the product pipelines in general of Bio-Thera Solutions and Hikma. Readers are strongly cautioned that ...