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NEWS

Amneal Pharmaceuticals and mAbxience’s Boncresa and Oziltus (Biosimilar, Prolia and Xgeva) Receive the US FDA’s Approval 

 Shots:  The US FDA has approved Boncresa (denosumab-mobz), a biosimilar version of Prolia, and Oziltus (denosumab-mobz), a biosimilar version of Xgeva  Denosumab is an mAb that reduces bone resorption and is used in oncology and osteoporosis indications   Under the Amneal and mAbxience collaboration, mAbxience manages development and manufacturing, and Amneal has exclusive US commercialization rights  Ref: Amneal Pharmaceuticals| Image: Amneal Pharmaceuticals and mAbxience | Press Release Related News:- Kashiv BioSciences and Amneal…
December 22, 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 recommendation Denbrayce prevents skeletal-related events in adults with bone-involved malignancies & treats giant cell tumors of bone in adults & skeletally mature adolescents Izamby is indicated to treat osteoporosis in postmenopausal women & men at increased risk…
July 3, 2025

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NEWS

mAbxience and Abiogen Pharma Enter into a Strategic Licensing Agreement for Biosimilar across Italy

Shots:  mAbxience, majority-owned by Fresenius Kabi and partially by Insud Pharma, has partnered with Abiogen Pharma in a strategic licensing agreement to develop & commercialize a biosimilar in Italy  As per the agreement, mAbxience will hold marketing authorization, while Abiogen Pharma handles commercialization and marketing in Italy  This collaboration leverages mAbxience’s biosimilar development expertise and…
May 26, 2025

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NEWS

Teva Pharmaceuticals and mAbxience Join Hands to Develop Biosimilar Candidates for Treating Oncology Indications 

Shots:  Teva Pharmaceuticals and mAbxience have signed a strategic licensing agreement across various markets incl. the EU and the US to develop a biosimilar product that is under development as a treatment for various oncology indications  As per the agreement, mAbxience will develop and produce the candidates by utilizing the knowledge of biosimilar development &…
April 4, 2024

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Insights+ Key Biosimilars Events of April 2021
INSIGHTS+

Insights+ Key Biosimilars Events of April 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of April, Biocon and Viatris received EC's approval for…
May 6, 2021

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Insights+ Key Biosimilars Events of March 2021
INSIGHTS+

Insights+ Key Biosimilars Events of March 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of March, Samsung Bioepis Initiated P-I Study of SB17…
April 1, 2021

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Insights+ Key Biosimilars Events of February 2020
INSIGHTS+

Insights+ Key Biosimilars Events of February 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients The Korean firm, Celltrion's Remsima also showed some updates in fields of approval and…
March 6, 2020

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