Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : 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
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Dr. Reddy's Laboratories
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : STADA Arzneimittel
Deal Size : Undisclosed
Deal Type : Partnership
Alvotech and STADA Add to Strategic Alliance Through Denosumab Partnership
Details : The partnership aims to cover AVT03, a clinical-stage biosimilar candidate referencing the Prolia®/Xgeva® (denosumab) medicines for osteoporosis and cancer-related bone loss respectively.
Product Name : AVT03
Product Type : Antibody
Upfront Cash : Undisclosed
November 06, 2024
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : STADA Arzneimittel
Deal Size : Undisclosed
Deal Type : Partnership
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EMA Confirms Marketing Application For Prolia®/Xgeva® Biosimilar AVT03
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
October 10, 2024
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Alvotech Reports Positive Results for AVT03, a Proposed Biosimilar for Prolia® and Xgeva®
Details : AVT03 (denosumab) is a biosimilar of Prolia and Xgeva, designed for use in postmenopausal women with osteoporosis. This medication is administered subcutaneously and functions as a RANKL inhibitor.
Product Name : AVT03
Product Type : Antibody
Upfront Cash : Inapplicable
February 07, 2024
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AVT03 is human mAB and biosimilar candidate to Prolia® and Xgeva® (denosumab), targets and binds with high affinity and specificity to RANK ligand membrane protein, preventing RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast...
Product Name : AVT03
Product Type : Antibody
Upfront Cash : Inapplicable
August 25, 2022
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Alvotech Initiates a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia and Xgeva
Details : AVT03 (denosumab), is human mAB that targets high affinity and specificity to RANK ligand membrane protein, preventing RANK ligand from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced...
Product Name : AVT03
Product Type : Antibody
Upfront Cash : Inapplicable
July 20, 2022
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable