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Switching Studies Is Not Needed for Interchangeability

Source link : https://www.newshealth.biz/health-news/switching-studies-is-not-needed-for-interchangeability/

The US Food and Drug Administration (FDA) has issued new draft guidance that does not require additional switching studies for biosimilars seeking interchangeability. These studies were previously recommended to demonstrate that switching between the biosimilar and its reference product showed no greater risk than using the reference product alone. “The recommendations in today’s draft guidance, […]

Author : News Health

Publish date : 2024-06-26 10:39:06

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