Teva Says FDA Has Accepted, And The European Medicines Agency Has Validated, Applications For TVB-009P, A Biosimilar Candidate To Prolia
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Teva Pharmaceutical Industries Ltd. announced that the FDA has accepted and the European Medicines Agency has validated applications for TVB-009P, a biosimilar candidate to Prolia. Decisions from both agencies are expected in the second half of 2025.
October 08, 2024 | 11:01 am
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Teva's biosimilar candidate to Prolia, TVB-009P, has been accepted by the FDA and validated by the EMA. This marks a significant step in Teva's biosimilar portfolio expansion, with regulatory decisions expected in the second half of 2025.
The acceptance and validation of TVB-009P by the FDA and EMA are positive developments for Teva, indicating progress in their biosimilar pipeline. This could enhance Teva's market position and revenue potential if approved, leading to a likely positive short-term impact on the stock.
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