Biosimilars

Latest News

FDA Approves Denosumab-Kyqq as Biosimilar for Prolia, Xgeva
FDA Approves Denosumab-Kyqq as Biosimilar for Prolia, Xgeva

September 17th 2025

The FDA also grants the biosimilar provisional interchangeability designation, making the drug substitutable at the pharmacy level.

FDA Approves Biosimilars for Prolia, Xgeva
FDA Approves Biosimilars for Prolia, Xgeva

September 2nd 2025

FDA Grants Interchangeability Designation to Adalimumab-Bwwd for Humira
FDA Grants Interchangeability Designation to Adalimumab-Bwwd for Humira

May 28th 2025

FDA Approves Ustekinumab-Hmny as Biosimilar to Stelara
FDA Approves Ustekinumab-Hmny as Biosimilar to Stelara

May 27th 2025

FDA Grants Expanded Interchangeability Designation to Yuflyma
FDA Grants Expanded Interchangeability Designation to Yuflyma

May 23rd 2025

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