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Celltrion
News

Celltrion Launches Osenvelt and Stoboclo (Biosimilars, Xgeva and Prolia) in the US

Shots:Celltrion has launched Osenvelt & Stoboclo, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) in the USStoboclo (60mg/mL) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer & women on adjuvant aromatase inhibitors…
5 days ago

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News

Biocon Biologics Receives the EC’s Approval for Vevzuo and Evfraxy (Biosimilars, Xgeva and Prolia)

Shots:The EC has approved Vevzuo & Evfraxy, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) following the CHMP positive opinion in Apr 2025Approval was based on the comprehensive clinical data, which showed comparable PK, safety, efficacy & immunogenicity of Vevzuo & Evfraxy to the reference productVevzuo prevents SREs in adults with bone-involved malignancies…
July 4, 2025

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News

mAbxience Reports the EC’s Approval of Denbrayce and Izamby (Biosimilar, Xgeva and Prolia)

Shots:The EC has approved Denbrayce & Izamby, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) following the CHMP’s recommendationDenbrayce prevents skeletal-related events in adults with bone-involved malignancies & treats giant cell tumors of bone in adults & skeletally mature adolescentsIzamby is indicated to treat osteoporosis in postmenopausal women & men at increased risk…
July 3, 2025

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Sandoz
News

Sandoz Launches Wyost and Jubbonti (Biosimilars, Xgeva and Prolia) in the US

Shots:Sandoz has launched Wyost & Jubbonti, interchangeable biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) in the USJubbonti (60mg/1mL) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer & women on adjuvant aromatase…
June 2, 2025

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Biocon Biologics
News

Biocon Biologics Receives CHMP’s Positive Opinion for Vevzuo and Denosumab BBL (Biosimilars, Xgeva and Prolia)

Shots:The CHMP has recommended Vevzuo & Denosumab BBL (brand name under approval), biosimilars of Xgeva & Prolia (denosumab)Opinion was based on the comprehensive clinical data submitted by Biosimilar Collaborations Ireland (Biocon Biologics’ subsidiary) incl. trials, which showed comparable PK, safety, efficacy & immunogenicity to the referenceDenosumab is a mAb that works by targeting…
April 29, 2025

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Gedeon Richter
News

Gedeon Richter Receives CHMP’s Positive Opinion for Junod and Yaxwer (Biosimilars, Prolia and Xgeva) 

Shots: The CHMP has recommended marketing authorization for Junod and Yaxwer, biosimilars of Amgen’s Xgeva & Prolia (denosumab) Denosumab is approved to treat postmenopausal osteoporosis, prevent bone complications from cancer metastases, and treat unresectable giant cell tumors of bone Junod & Yaxwer are mAbs (IgG2) that block RANKL, preventing osteoclast activation  Ref: Gedeon Richter | Image: Gedeon Richter…
April 25, 2025

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Alvotech and Dr. Reddy's
News

Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva) 

Shots: The US FDA has accepted 351(k) BLA of AVT03, a biosimilar version of Prolia & Xgeva (denosumab), for all indications of reference product As per the 2024 license & supply agreement, Alvotech is responsible for the development & manufacturing of AVT03, while Dr. Reddy’s handles registration & marketing in licensed regions, incl. the U.S. …
March 18, 2025

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