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    Denosumab

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    Accord healthcare

    United Kingdom
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    Accord healthcare

    United Kingdom
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    Regulatory Info : Approved

    Registration Country : Sweden

    Denosumab

    Brand Name : Jubereq

    Dosage Form : Injectable Solution

    Dosage Strength : 120mg

    Packaging :

    Approval Date : 26/05/2025

    Application Number : 20240307000028

    Regulatory Info : Approved

    Registration Country : Sweden

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    02

    Amgen Inc

    U.S.A
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    Amgen Inc

    U.S.A
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    Regulatory Info :

    Registration Country : USA

    DENOSUMAB

    Brand Name : PROLIA

    Dosage Form : INJECTABLE; SUBCUTANEOUS

    Dosage Strength : 60MG/ML

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    Approval Date :

    Application Number : 125320

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    Registration Country : USA

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    03

    Amgen Inc

    U.S.A
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    Amgen Inc

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    Registration Country : USA

    DENOSUMAB

    Brand Name : XGEVA

    Dosage Form : INJECTABLE; SUBCUTANEOUS

    Dosage Strength : 70MG/ML

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    Approval Date :

    Application Number : 125320

    Regulatory Info :

    Registration Country : USA

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    04

    Amgen Inc

    U.S.A
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    Regulatory Info :

    Registration Country : Norway

    Denosumab

    Brand Name : Xgeva

    Dosage Form : Solution for injection, solution in pre-filled syringe

    Dosage Strength : 120 mg

    Packaging : Pre-filled syringe 1ml

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    Registration Country : Norway

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    05

    Celltrion

    South Korea
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    Celltrion

    South Korea
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    Registration Country : USA

    DENOSUMAB-BMWO

    Brand Name : STOBOCLO

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 60MG/ML

    Packaging :

    Approval Date :

    Application Number : 761404

    Regulatory Info :

    Registration Country : USA

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    06

    Celltrion

    South Korea
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    Celltrion

    South Korea
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    Regulatory Info :

    Registration Country : USA

    DENOSUMAB-BMWO

    Brand Name : OSENVELT

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 120MG/1.7ML(70MG/ML)

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    Approval Date :

    Application Number : 761404

    Regulatory Info :

    Registration Country : USA

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    07

    Fresenius Kabi USA

    U.S.A
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    Fresenius Kabi USA

    U.S.A
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    Regulatory Info :

    Registration Country : USA

    DENOSUMAB-BNHT

    Brand Name : BOMYNTRA

    Dosage Form : INJECTION

    Dosage Strength : 120MG/1.7ML (70 MG/ML)

    Packaging :

    Approval Date :

    Application Number : 761398

    Regulatory Info :

    Registration Country : USA

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    08

    Fresenius Kabi USA

    U.S.A
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    Fresenius Kabi USA

    U.S.A
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    Regulatory Info :

    Registration Country : USA

    DENOSUMAB-BNHT

    Brand Name : CONEXXENCE

    Dosage Form : INJECTION

    Dosage Strength : 60MG/ML

    Packaging :

    Approval Date :

    Application Number : 761398

    Regulatory Info :

    Registration Country : USA

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    09

    Gedeon Richter

    Hungary
    The MedTech Conference
    Not Confirmed
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    Gedeon Richter

    Hungary
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    The MedTech Conference
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    Regulatory Info : Approved

    Registration Country : Sweden

    Denosumab

    Brand Name : Junod

    Dosage Form : Solution For Injection

    Dosage Strength : 60mg

    Packaging :

    Approval Date : 23/06/2025

    Application Number : 20240701000372

    Regulatory Info : Approved

    Registration Country : Sweden

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    10

    Mabxience

    Spain
    The MedTech Conference
    Not Confirmed
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    Mabxience

    Spain
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    The MedTech Conference
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    Regulatory Info : Approved

    Registration Country : Sweden

    Denosumab

    Brand Name : Denbrayce

    Dosage Form : Injectable Solution

    Dosage Strength : 120mg

    Packaging :

    Approval Date : 26/06/2025

    Application Number : 20240424000048

    Regulatory Info : Approved

    Registration Country : Sweden

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    11

    Mabxience

    Spain
    The MedTech Conference
    Not Confirmed
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    Mabxience

    Spain
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    The MedTech Conference
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    Regulatory Info : Approved

    Registration Country : Sweden

    Denosumab

    Brand Name : Izamby

    Dosage Form : Solution For Injection

    Dosage Strength : 60mg

    Packaging :

    Approval Date : 26/06/2025

    Application Number : 20240424000024

    Regulatory Info : Approved

    Registration Country : Sweden

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    12

    Samsung Bioepis

    South Korea
    The MedTech Conference
    Not Confirmed
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    Samsung Bioepis

    South Korea
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    The MedTech Conference
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    Regulatory Info :

    Registration Country : USA

    DENOSUMAB-DSSB

    Brand Name : OSPOMYV

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 60MG/ML

    Packaging :

    Approval Date :

    Application Number : 761392

    Regulatory Info :

    Registration Country : USA

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    13

    Samsung Bioepis

    South Korea
    The MedTech Conference
    Not Confirmed
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    Samsung Bioepis

    South Korea
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    The MedTech Conference
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    Regulatory Info :

    Registration Country : USA

    DENOSUMAB-DSSB

    Brand Name : XBRYK

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 70MG/ML

    Packaging :

    Approval Date :

    Application Number : 761392

    Regulatory Info :

    Registration Country : USA

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    14

    Samsung Bioepis

    South Korea
    The MedTech Conference
    Not Confirmed
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    Samsung Bioepis

    South Korea
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    The MedTech Conference
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    Regulatory Info :

    Registration Country : USA

    DENOSUMAB-DSSB

    Brand Name : DENOSUMAB-DSSB

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 60MG/ML

    Packaging :

    Approval Date :

    Application Number : 761392

    Regulatory Info :

    Registration Country : USA

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    15

    Samsung Bioepis

    South Korea
    The MedTech Conference
    Not Confirmed
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    Samsung Bioepis

    South Korea
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    The MedTech Conference
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    Regulatory Info :

    Registration Country : USA

    DENOSUMAB-DSSB

    Brand Name : DENOSUMAB-DSSB

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 70MG/ML

    Packaging :

    Approval Date :

    Application Number : 761392

    Regulatory Info :

    Registration Country : USA

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    16

    Samsung Bioepis

    South Korea
    The MedTech Conference
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    Samsung Bioepis

    South Korea
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    The MedTech Conference
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    Regulatory Info : Approved

    Registration Country : Sweden

    Denosumab

    Brand Name : Obodence

    Dosage Form : Solution For Injection

    Dosage Strength : 60mg

    Packaging :

    Approval Date : 12/02/2025

    Application Number : 20240308000126

    Regulatory Info : Approved

    Registration Country : Sweden

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    17

    Sandoz B2B

    Switzerland
    The MedTech Conference
    Not Confirmed
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    Sandoz B2B

    Switzerland
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    The MedTech Conference
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    Regulatory Info :

    Registration Country : USA

    DENOSUMAB-BBDZ

    Brand Name : JUBBONTI

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 60MG/ML

    Packaging :

    Approval Date :

    Application Number : 761362

    Regulatory Info :

    Registration Country : USA

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    18

    Sandoz B2B

    Switzerland
    The MedTech Conference
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    Sandoz B2B

    Switzerland
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    The MedTech Conference
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    Registration Country : USA

    DENOSUMAB-BBDZ

    Brand Name : WYOST

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 120MG/1.7ML (70MG/ML)

    Packaging :

    Approval Date :

    Application Number : 761362

    Regulatory Info :

    Registration Country : USA

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    19

    Sandoz B2B

    Switzerland
    The MedTech Conference
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    Sandoz B2B

    Switzerland
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    The MedTech Conference
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    Regulatory Info : Approved

    Registration Country : Sweden

    Denosumab

    Brand Name : Jubbonti

    Dosage Form : Solution For Injection

    Dosage Strength : 60mg

    Packaging :

    Approval Date : 16/05/2024

    Application Number : 20230426000016

    Regulatory Info : Approved

    Registration Country : Sweden

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    20

    Biosimilar Collaborations Ireland L...

    Country
    The MedTech Conference
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    Biosimilar Collaborations Ireland L...

    Country
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    The MedTech Conference
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    Regulatory Info : Approved

    Registration Country : Sweden

    Denosumab

    Brand Name : Evfraxy

    Dosage Form : Solution For Injection

    Dosage Strength : 60mg

    Packaging :

    Approval Date : 30/06/2025

    Application Number : 20240802000295

    Regulatory Info : Approved

    Registration Country : Sweden

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