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 The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...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 release of a recent EMA reflection paper, aligning with FDA and WHO positions, has resulted in a renewed focus on the central role of pharmacokinetic (PK) data, the primary status of analytical ...

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 ...

AMRX targets 2027 upside through biosimilars scale, new complex launches, and Specialty recovery after 2026 Rytary erosion ...

Alvotech, a biotech firm focused on biosimilar medicine development, announced the acquisition of Xbrane Biopharma’s R&D operations and a biosimilar candidate named XB003, aimed at extending its ...

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 ...

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 ...

Samsung Bioepis Co., Ltd. today released its Second Quarter 2026 Biosimilar Market Report, marking the thirteenth edition of ...

A new independent analysis of the US Food and Drug Administration's (FDA) workload around biosimilars over the first three years shows how biosimilar development has slowly progressed as companies ...

Amneal Pharmaceuticals AMRX is leaning into a playbook that can work in multiple market backdrops. The company is pairing ...

(Reuters) -India's Biocon expects a 50% drop in costs for developing complex biosimilars as the United States has proposed to ease clinical testing for the drugs that make up more than 60% of its ...