A slew of brand-name biological drugs are due to lose patent protection in the next decade. But lower-cost versions are only in the pipeline for 1 out of 10, according to industry estimates. Why it ...

U.S. biosimilars have generated $81.6B in cumulative savings since 2015, including $56B to health systems, with HHS citing launch pricing ~50% below reference biologics. From a 95% remission rate in ...

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 The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...

With no off-patent versions currently in development for 90% of brand-name biologics losing market exclusivity over the next ...

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

Michael Ellenberger, Aydin Harston Ph.D. On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for ...

Abxience, a majority-owned company of Fresenius SE & Co. KGaA (XETR: FRE) (OTCM: FSNUY) with partial ownership from Insud Pharma; and Sandoz (SIX: SDZ) (OTCQX: SDZNY), the global leader in affordable ...

Xentria announces operational milestone with expansion of multiple clinical trials in 11 countries and 3 regions across their portfolio. Advancements in operational infrastructure allows for further ...

The updated guidance allows originators to cite existing comparative data, not exclusively from the United States, for clinical pharmacokinetic testing. This updated guidance in conjunction with ...

Cathy Burgess, Yifan Wang, Ph.D. Our FDA: Drug & Device Team explores the Food and Drug Administration’s updated draft guidance that eases biosimilar development by allowing greater use of ...

Sandoz announced the creation of a new global biosimilar development, manufacturing, and supply unit as the Swiss medicines maker prepares to capitalize on a wave of biologic drugs losing patent ...