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Drugs in Development
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.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Brand Name: Vevzuo
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 28, 2025
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Upfront Cash : Inapplicable
April 28, 2025
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.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Brand Name: BP16
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 09, 2025
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : BP16
Product Type : Antibody
Upfront Cash : Inapplicable
April 09, 2025
Details:
Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) received FDA approval for all indications of the reference products: Prolia and Xgeva respectively.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Brand Name: Conexxence
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 27, 2025
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Upfront Cash : Inapplicable
March 27, 2025
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.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Brand Name: AVT03
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Dr. Reddy's Laboratories
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 17, 2025
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Dr. Reddy's Laboratories
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : AVT03
Product Type : Antibody
Upfront Cash : Inapplicable
March 17, 2025
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)
Lead Product(s): Denosumab
Therapeutic Area: Oncology Brand Name: Osenvelt
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 03, 2025
Lead Product(s) : Denosumab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Upfront Cash : Inapplicable
March 03, 2025
Details:
Stoboclo (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia. It is a RANK ligand inhibitor, which is indicated for postmenopausal osteoporosis.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Brand Name: Stoboclo
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 03, 2025
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Celltrion Gets FDA Nod for STOBOCLO®, OSENVELT® Biosimilars
Details : Stoboclo (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 : Stoboclo
Product Type : Antibody
Upfront Cash : Inapplicable
March 03, 2025
Details:
MB09 (denosumab), referencing Xgeva, is being evaluated for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone)
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Brand Name: MB09
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Mabxience
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 03, 2025
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Mabxience
Deal Size : Inapplicable
Deal Type : Inapplicable
Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA
Details : MB09 (denosumab), referencing Xgeva, is being evaluated for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone)
Product Name : MB09
Product Type : Antibody
Upfront Cash : Inapplicable
March 03, 2025
Details:
Xbryk (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)
Lead Product(s): Denosumab
Therapeutic Area: Oncology Brand Name: Xbryk
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 15, 2025
Lead Product(s) : Denosumab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Samsung Bioepis Gains EC Approval for Denosumab Biosimilar Obodence, Xbryk
Details : Xbryk (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 : Xbryk
Product Type : Antibody
Upfront Cash : Inapplicable
February 15, 2025
Details:
Obodence (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia. It is a RANK ligand inhibitor, which is indicated for postmenopausal osteoporosis.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Brand Name: Obodence
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 15, 2025
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Samsung Bioepis Gains EC Approval for Denosumab Biosimilar Obodence, Xbryk
Details : Obodence (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 : Obodence
Product Type : Antibody
Upfront Cash : Inapplicable
February 15, 2025
Details:
Ospomyv (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia. It is a RANK ligand inhibitor, which is indicated for postmenopausal osteoporosis.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Brand Name: Ospomyv
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 15, 2025
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves Samsung Bioepis’ Ospomyv, Xbryk, a Biosimilar to Prolia & Xgeva
Details : Ospomyv (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 : Ospomyv
Product Type : Antibody
Upfront Cash : Inapplicable
February 15, 2025
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