Riley Wyberg

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Latest Posts › FDA Approval

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FDA Approves Bio-Thera and Hikma’s Ustekinumab Biosimilar

On May 22, 2025, the FDA approved Bio-Thera Solutions and Hikma Pharmaceuticals’ ustekinumab biosimilar, STARJEMZA® (ustekinumab-hmny) injection, referencing Janssen’s STELARA® (ustekinumab) injection....more

5/29/2025 / Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Prescription Drugs

FDA Approves Fresenius’s Denosumab Biosimilars

On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), referencing Amgen’s PROLIA® and XGEVA®, respectively. These approvals make Fresenius...more

3/28/2025 / Amgen , Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Fresenius , Pharmaceutical Industry , Pharmaceutical Patents , Prescription Drugs

FDA Approves Celltrion’s Denosumab Biosimilars

On March 3, 2025, the FDA approved Celltrion’s denosumab biosimilars, STOBOCLO® (denosumab-bmwo; 60 mg/mL injection) and OSENVELT® (denosumab-bmwo; 70 mg/mL injection), referencing Amgen’s PROLIA® and XGEVA®, respectively....more

3/7/2025 / Biosimilars , Celltrion , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

FDA Approves Celltrion’s AVTOZMA (tocilizumab-anoh)

On January 31, 2025, Celltrion announced that the FDA approved its tocilizumab biosimilar, AVTOZMA® (tocilizumab-anoh), referencing Genentech’s ACTEMRA®....more

2/4/2025 / Biologics , Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

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