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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 US Jubbonti (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 reference Denosumab 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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Accord Healthcare
NEWS

Accord Healthcare Reports the CHMP’s Positive Opinion on Osvyrti and Jubereq (Biosimilar, Prolia & Xgeva)

Shots: The CHMP has recommended Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab); launch expected post patent expiry of reference products in Nov 2025 Osvyrti (60mg pre-filled syringe) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It also used to treat bone loss in pts…
April 3, 2025

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Fresenius Kabi
NEWS

The US FDA Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved BLA of Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) for all indications of the reference products Approval was supported by extensive analytical development & similarity assessment based on 2 trials: one assessing its PK, PD, & immunogenicity in healthy volunteers, & other evaluating its efficacy, PD, safety,…
March 27, 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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NEWS

Alvotech Collaborates with Dr. Reddy’s to Commercialize AVT03 (Biosimilar, Prolia & Xgeva) 

  Shots:  Alvotech & Dr. Reddy’s have signed a license & supply agreement to commercialize AVT03 under which Alvotech will handle the development & manufacturing activities. Dr. Reddy will get regulatory & commercial rights exclusively in US and semi-exclusively in the EU & UK   Alvotech will receive an upfront, regulatory & commercial milestones as well as…
May 21, 2024

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Sandoz
NEWS

Sandoz Reports the US FDA’s Approval of Wyost and Jubbonti (Biosimilar, Denosumab)

Shots:  Sandoz has received the US FDA’s approval for Wyost & Jubbonti (denosumab-bbdz), biosimilars of Xgeva & Prolia (denosumab), based on the clinical studies demonstrating their similarity with the reference drugs  The company’s Jubbonti Risk Evaluation & Mitigation Strategy (REMS) program has also been approved to educate HCPs & patients about the severe hypocalcemia risk…
March 5, 2024

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NEWS

Boan Biotech Highlights Clinical Updates for BA6101 (biosimilar, Prolia) and BA1102 (biosimilar, Xgeva) to Treat Various Indications 

Shots: The company has completed patient enrolment in P-III trial which evaluates the safety, efficacy, PK & immunogenicity of BA6101 & BA1102 vs reference drugs (Prolia & Xgeva) for the treatment of various indication across Europe, United States & Japan  Boan also conducted a meeting in Germany to highlight the PK results from the…
January 15, 2024

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