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Biosimilar Information Wars: Draft Guidance Seeks To Clamp Down On Efforts To Hinder Uptake In The US

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The US FDA said in draft guidance that accurate information comparing a biosimilar and its reference could be considered misleading if offered in the wrong context.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

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biosimilars are inferior or different from their reference products in promotional campaigns, indicating in new draft guidance that the statements likely would be misleading.

The draft guidance released on 3 February offers considerations for reference biologic and biosimilar sponsors when designing promotional labeling and advertisements

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