FDA's Bold Steps to Boost Biosimilar Development
The U.S. FDA is streamlining biosimilar development with new draft guidance to simplify studies and reduce unnecessary testing. This initiative aims to lower drug costs and facilitate the interchangeability of biosimilars with brand-name biologics, by easing resource-intensive comparative clinical study requirements.
The U.S. Food and Drug Administration (FDA) is taking significant steps to accelerate the development of biosimilars and reduce drug costs by issuing new draft guidance.
This guidance suggests substantial updates to simplify biosimilarity studies and cut down on unnecessary clinical testing.
As part of a separate initiative, the FDA aims to make it more straightforward for biosimilars to achieve interchangeability with brand-name biologics, thereby reducing the burden of resource-intensive comparative human clinical studies for developers.
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