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

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

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

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

This framework is the second that the agency has introduced in recent months to streamline biosimilar development in the ...

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 The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...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.

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

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

The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen (filgrastim), for use in cancer patients at risk of infection due to chemotherapy. Filkri is indicated for patients receiving ...