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Biosimilar Labeling In US Needs Greater Transparency, BIO And PhRMA Say

 
• By Sue Sutter

The US Food and Drug Administration's current approach to biosimilar labeling lacks transparency and requires changes to align with the agency's own Transparency Initiative, a joint citizen petition from two biopharmaceutical trade groups suggests1.

The US Food and Drug Administration's current approach to biosimilar labeling lacks transparency and requires changes to align with the agency's own Transparency Initiative, a joint citizen petition from two biopharmaceutical trade groups suggests1.

The Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) petitioned the FDA to include in biosimilar product labeling certain information that will provide

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