Shots:
- The US FDA and the EMA has accepted Teva’s applications for TVB-009P, biosimilar version of Prolia (denosumab), for all the approved indications, with their decisions anticipated during H2’25
- Submissions were built upon the data from P-III (TVB009-IMB-30085) study assessing safety & efficacy of TVB-009P vs Prolia among women with postmenopausal osteoporosis as well as from PK/PD trial (TVB009-BE-10157) among healthy subjects showing similarity b/w the drugs
- TVB-009P is a monoclonal antibody that works by targeting RANKL which regulates bone metabolism and osteoclast formation
Ref: Teva Pharmaceutical | Image: Teva Pharmaceutical | Press Release
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