Teva Pharmaceutical Industries Ltd. TEVA announced that the FDA has approved its biosimilar to Amgen’s AMGN blockbuster drug, ...

Teva’s biosimilar, PONLIMSI™, is now FDA-approved across all indications of the reference product, Prolia ® (denosumab), to treat a variety of ...

The FDA approval for Ponlimsi is based on comprehensive evidence, including analytical and clinical data.

On March 30, 2026, the FDA approved Ponlimsi, a biosimilar to Prolia, and is reviewing a biosimilar candidate for Xolair.

Announced positive initial comparative analytical results, confirming identical amino-acid sequencing and highly similar functional ...

Add Yahoo as a preferred source to see more of our stories on Google. The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...

The Food and Drug Administration has approved Teva's Prolia biosimilar and the agency is reviewing Teva's Xolair biosimilar application.

Israel-based Teva Pharmaceutical Industries today announced three milestones in its biosimilar portfolio, demonstrating ...

Biologic copycats are making a bigger impact on drug prices as U.S. regulators open the doors wider, and new guidance could ...

Please provide your email address to receive an email when new articles are posted on . Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co.), a HER2 receptor antagonist and biosimilar to ...