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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Draft Guidance Seeks To Clamp Down On Efforts To Hinder Uptake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biosimilars are inferior or different from their reference products in promotional campaigns, indicating in new draft guidance that the statements likely would be misleading.

The draft guidance released on 3 February offers considerations for reference biologic and biosimilar sponsors when designing promotional labeling...

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