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FDA Warns Over Denigrating Biosimilars

Draft Guidance Seeks To Clamp Down On Efforts To Hinder Uptake

 
• By Derrick Gingery

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

US Food and Drug Administration officials have offered a clear warning against suggesting biosimilars are inferior or different from their reference products in promotional campaigns, indicating in new draft guidance that the statements likely would be misleading.

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