FDA Warns Over Denigrating Biosimilars

Draft Guidance Seeks To Clamp Down On Efforts To Hinder Uptake

The guidance states that promotion creating an impression that differences are clinically meaningful when the US FDA has said they are not could be judged misleading.

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The FDA said accurate information comparing a biosimilar and its reference product could be considered misleading if offered in the wrong context • Source: Shutterstock

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