Teva Pharmaceutical Receives FDA Approval For PONLIMSI As Biosimilar To Prolia, And Application For Biosimilar To Xolair

Teva Pharmaceutical Industries Ltd. has received FDA approval for PONLIMSI (denosumab-adet) as a biosimilar to Prolia, supporting its Pivot to Growth strategy. The approval was based on evidence showing similar efficacy and safety to the reference product, Prolia, and PONLIMSI is approved for all indications of Prolia. Additionally, Teva's applications for a biosimilar candidate to Xolair (omalizumab) have been accepted by both the U.S. FDA and the European Medicines Agency.