Teva Receives FDA Approval for Prolia Biosimilar

Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab)

Teva’s biosimilar, PONLIMSI™, is now FDA-approved across all indications of the reference product, Prolia® (denosumab), to treat a variety of debilitating bone conditions.Teva’s proposed biosimilar candidate to Xolair® (omalizumab) is accepted for review by U.S. FDA and EU EMA.These milestones…

FDA Approves Teva Biosimilar for Denosumab in Osteoporosis

The FDA approved Teva’s biosimilar for denosumab, and the FDA and EMA accepted its asthma biosimilar application for review.

Teva receives FDA approval for Prolia biosimilar

Teva Pharmaceutical has announced the US FDA approval for Ponlimsi as a biosimilar to Prolia, alongside the acceptance of its biosimilar candidate applications for Xolair by both the agency and the EMA.