Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®

Approvals expand Amneal’s biosimilars portfolioCompany expects to commercialize six biosimilars across eight presentations by 2027 BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal ...
Drug Store News

Sandoz reaches agreement with Amgen on denosumab biosimilars

Sandoz shared that it has reached agreement with Amgen to resolve all patent disputes between the two companies relating to the Food and Drug Administration approved Sandoz denosumab biosimilars.
Drug Store News

Celltrion receives FDA nod for Prolia, Xgeva biosimilars

Celltrion has received permission from the Food and Drug Administration for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Prolia (denosumab) and ...
Monthly Prescribing Reference

FDA Approves Updated ONJ Warning for Prolia, Xgeva

The Food and Drug Administration (FDA) has approved supplemental Biologics License Applications (sBLA) for Amgen's Prolia (denosumab) and Xgeva (denosumab). The proposed sBLA includes the addition ...
FiercePharma

FDA approves new indication for Prolia® (Denosumab) for the treatment of bone loss in men with osteoporosis at high risk for fracture

Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) approved a new indication for Prolia® (denosumab) as a treatment to increase bone mass in men with osteoporosis at high ...
Investing.com India

Amneal stock rises after FDA approves two denosumab biosimilars

Investing.com -- Amneal Pharmaceuticals Inc Class A (NASDAQ:AMRX) stock rose 2% in after-hours trading on Monday after the company announced FDA approval for two biosimilar drugs, expanding its ...
FiercePharma

FDA Approves Amgen's Prolia(TM) (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture

THOUSAND OAKS, Calif., June 1 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Prolia ...

Mabxience And Amneal Announces FDA Approval Of Denosumab Biosimilars Referencing Prolia® And XGEVA®

Mabxience And Amneal Announces FDA Approval Of Denosumab Biosimilars Referencing Prolia® And XGEVA®. mAbxience / Key word(s): Miscellaneous mAbxience and Amneal Announces FDA Approval of Denosumab ...

Amneal Pharmaceuticals, Inc.: Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia and XGEVA

Approvals expand Amneal's biosimilars portfolioCompany expects to commercialize six biosimilars across eight presentations by 2027 BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceu ...