Teva Reports the Acceptance of Regulatory Submissions for TVB-009P (Biosimilar, Prolia) by the US FDA and EMA
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
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
