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FDA looks to simplify biosimilar development with new draft guidance

The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...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

Dr. Oz and FDA chief say biosimilar drug reform will lower prices

Dr. Mehmet Oz and Dr. Marty Makary touted that reducing steps for biosimilar approval will lower costs by increasing competition.
Healthcare 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 ...

DR. MAKARY, DR OZ: People talk about lowering healthcare costs, but the Trump administration is doing it

FDA announces major reforms to streamline biosimilar approvals, potentially saving Americans billions on prescription drug ...
JD Supra

FDA Issues Updated Framework for Biosimilar Reviews

On Wednesday, Oct. 29, the Food and Drug Administration (FDA) issued draft guidance proposing to update its biosimilar review framework. Under the ...

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 biological drugs, the agency announced Wednesday. The changes are meant to ...