Source link : https://www.newshealth.biz/health-news/fda-plans-to-ease-requirements-for-biosimilars-interchangeable-status/
The FDA on Thursday announced that biosimilars seeking an interchangeable status would no longer require studies showing that switching between a biosimilar and its branded reference product does not present any potential safety risks or risk of diminished efficacy. In new draft guidance, the agency is suggesting a “revised approach where such studies will generally […]
Author : News Health
Publish date : 2024-06-20 21:36:44
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