GlobalData on MSN

FDA looks to simplify biosimilar development with new draft guidance

The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...
BioPharma Dive

FDA, aiming to lower drug costs, moves to speed approval of biosimilars

The agency will no longer require studies comparing copycat biologics to their branded counterparts, which could help ...
The American Journal of Managed Care

FDA Guidance to Remove One of the Largest Barriers to Biosimilar Development

By emphasizing analytical studies instead of routine clinical trials, the FDA signals its intent to reduce the cost (often estimated at $100 million to $300 million) and time (typically 6–9 years) ...
Becker's Hospital Review

FDA rewrites biosimilar rules to slash drug costs

FDA rewrites biosimilar rules to speed development and lower costs for biologic drugs, supporting federal drug price reduction efforts.

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

The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex ...
American Medical Association

Oct. 31, 2025: National Advocacy Update

FDA issues new guidance aimed at speeding biosimilar time to market and lower costs, and more in the latest National Advocacy ...
BioSpace

FDA Proposes Lower Bar for Biosimilar Approvals in Bid To Lower Drug Prices

Generic versions of biologic drugs could hit the market without human trials and allow the market forces to bring down costs, ...