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and Treatment of Cancer \/ Amgen Inc","highestDevelopmentStatusID":"8","companyTruncated":"European Organisation for Research and Treatment of Cancer \/ Amgen Inc"},{"orgOrder":0,"company":"Biocon Biologics","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"INDIA","productType":"Antibody, Unconjugated","year":"2025","type":"Inapplicable","leadProduct":"Denosumab","moa":"Tumor necrosis factor ligand superfamily member 11","graph1":"Musculoskeletal","graph2":"Approved FDF","graph3":"Biocon Biologics","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Injection","sponsorNew":"Biocon Biologics \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Biocon Biologics \/ Undisclosed"},{"orgOrder":0,"company":"Alvotech","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"ICELAND","productType":"Antibody, 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                            Lead Product(s) : Denosumab

                            Therapeutic Area : Oncology

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

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                            Alvotech Announces Marketing Approval in Japan of Three New Biosimilars

                            Details : AVT03, approved in Japan as DENOSUMAB BS 120 mg/1.4 mL in a vial for subcutaneous injection, is a biosimilar to Ranmark® (denosumab), which is marketed in some other countries globally as Xgeva.

                            Product Name : Denosumab BS

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Inapplicable

                            September 19, 2025

                            Lead Product(s) : Denosumab

                            Therapeutic Area : Oncology

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            02

                            Celltrion

                            South Korea arrow
                            AAPS
                            Not Confirmed

                            Celltrion

                            South Korea arrow
                            AAPS
                            Not Confirmed
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                            • WHO-GMP
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                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Health Canada Approves Celltrion’s Stoboclo & Osenvelt Denosumab Biosimilars

                            Details : Stoboclo (denosumab) is a biosimilar antibody candidate, which is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

                            Product Name : Stoboclo

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Inapplicable

                            September 19, 2025

                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            03

                            Biocon Biologics

                            India arrow
                            AAPS
                            Not Confirmed

                            Biocon Biologics

                            India arrow
                            AAPS
                            Not Confirmed
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                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Biocon Biologics receives FDA approval for Bosaya and Aukelso biosimilars

                            Details : Bosaya (denosumab) is a biosimilar antibody candidate, which is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

                            Product Name : Bosaya

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Inapplicable

                            September 17, 2025

                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            04

                            Shanghai Henlius Biotech

                            China arrow
                            AAPS
                            Not Confirmed

                            Shanghai Henlius Biotech

                            China arrow
                            AAPS
                            Not Confirmed
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                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Study Phase : Approved FDF

                            Sponsor : Organon

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            FDA Approves Henlius and Organon’s Bildyos and Bilprevda

                            Details : Bildyos (denosumab) is a biosimilar antibody candidate, which is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

                            Product Name : Bildyos

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Inapplicable

                            September 02, 2025

                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Highest Development Status : Approved FDF

                            Sponsor : Organon

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            05

                            Biocon

                            India arrow
                            AAPS
                            Not Confirmed

                            Biocon

                            India arrow
                            AAPS
                            Not Confirmed
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                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            EU approves Biocon Biologics’ Denosumab biosimilars

                            Details : Vevzuo (denosumab) is authorised for the prevention of bone complications in adults with advanced cancer involving bone.

                            Product Name : Vevzuo

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Inapplicable

                            July 03, 2025

                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            06

                            Biocon

                            India arrow
                            AAPS
                            Not Confirmed

                            Biocon

                            India arrow
                            AAPS
                            Not Confirmed
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                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Study Phase : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Biocon Biosimilars Vevzuo and Denosumab BBL Receive Positive CHMP Opinion

                            Details : Vevzuo (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia. It is a RANK ligand inhibitor, which is indicated for postmenopausal osteoporosis.

                            Product Name : Vevzuo

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Inapplicable

                            April 28, 2025

                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Highest Development Status : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            07

                            CuraTeQ Biologics

                            India arrow
                            AAPS
                            Not Confirmed

                            CuraTeQ Biologics

                            India arrow
                            AAPS
                            Not Confirmed
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                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Study Phase : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            CuraTeQ Biologics Completes Phase 1 Pharmacokinetics Study of Biosimilar Denosumab

                            Details : BP16 (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia. It is a RANK ligand inhibitor, which is being evaluated for postmenopausal osteoporosis.

                            Product Name : Undisclosed

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Inapplicable

                            April 09, 2025

                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Highest Development Status : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            08

                            Fresenius Kabi AG

                            Germany arrow
                            AAPS
                            Not Confirmed

                            Fresenius Kabi AG

                            Germany arrow
                            AAPS
                            Not Confirmed
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                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Fresenius Wins FDA Nod for Denosumab Biosimilars, Reaches Global Deal

                            Details : Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) received FDA approval for all indications of the reference products: Prolia and Xgeva respectively.

                            Product Name : Conexxence

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Inapplicable

                            March 27, 2025

                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            09

                            Alvotech

                            Iceland arrow
                            AAPS
                            Not Confirmed

                            Alvotech

                            Iceland arrow
                            AAPS
                            Not Confirmed
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                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Study Phase : Phase III

                            Sponsor : Dr. Reddy\'s Laboratories

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Alvotech-Dr. Reddy’s FDA Filing Accepted for AVT03 Biosimilar to Prolia/Xgeva

                            Details : AVT03 (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia & Xgeva. It is a RANK ligand inhibitor, which is being evaluated in phase 1 trials for bone loss in adult men.

                            Product Name : Undisclosed

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Inapplicable

                            March 17, 2025

                            Lead Product(s) : Denosumab

                            Therapeutic Area : Musculoskeletal

                            Highest Development Status : Phase III

                            Sponsor : Dr. Reddy\'s Laboratories

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            10

                            Celltrion

                            South Korea arrow
                            AAPS
                            Not Confirmed

                            Celltrion

                            South Korea arrow
                            AAPS
                            Not Confirmed
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                            Lead Product(s) : Denosumab

                            Therapeutic Area : Oncology

                            Study Phase : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Celltrion Wins FDA Approval for STOBOCLO®, OSENVELT® Biosimilars

                            Details : Osenvelt (denosumab), referencing Xgeva, has been approved for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone)

                            Product Name : Osenvelt

                            Product Type : Antibody, Unconjugated

                            Upfront Cash : Inapplicable

                            March 03, 2025

                            Lead Product(s) : Denosumab

                            Therapeutic Area : Oncology

                            Highest Development Status : Approved FDF

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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