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…

ByRidhi RastogiApril 29, 2025

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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…

ByDipanshu DixitApril 25, 2025

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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 2025Osvyrti (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…

ByRidhi RastogiApril 3, 2025

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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 productsApproval 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,…

ByRidhi RastogiMarch 27, 2025

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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. …

ByDipanshu DixitMarch 18, 2025

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

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

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

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

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

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

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

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

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

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

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