In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The ...

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

This framework is the second that the agency has introduced in recent months to streamline biosimilar development in the hopes of lowering drug prices.

Aydin Harston Ph.D., Alexander Shaver Ph.D. FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025.

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 The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...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 administration announced some proposals for the Food And Drug Administration. (Sarah Silbiger/Getty Images) The Trump administration is proposing changes to Food and Drug Administration guidelines ...

In a policy shift that could benefit India’s biosimilar industry, the US Food and Drug Administration (FDA) this week announced reforms to simplify and reduce the cost of developing biosimilars, lower ...