Posted by Michael Wonder on 31 Mar 2026
Teva gains biosimilar momentum with US FDA approval of Ponlimsi (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab)
30 March 2026 - Teva Pharmaceutical Industries today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the advancement of its pivot to growth strategy.
The US FDA has approved Ponlimsi (denosumab-adet) as a biosimilar to Prolia, and Teva’s applications for a proposed biosimilar candidate to Xolair (omalizumab) have been accepted by both the US FDA and the EMA.
