Healio

Q&A: FDA update to biosimilar approval process may reduce time, cost of development

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
KSBW The Central Coast

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

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 ...
JD Supra

FDA Policy Changes Could Bring Some Biosimilars to Market Faster

The Food and Drug Administration (FDA) recently announced changes to its policy on when a comparative efficacy study would be required to demonstrate biosimilarity. In essence, FDA is lopping off the ...
JD Supra

New FDA Guidance Aims to Simplify the Biosimilar Approval Process

In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein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