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News and Press: Policy News

PhRMA, BIO Double Down on Biosimilar Naming With FDA Petition

Monday, January 25, 2016   (0 Comments)
Posted by: Kate Oesterle
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The nontrivial issue of how biosimilars should be named in the US may not go away until the US Food and Drug Administration (FDA) makes a definitive decision on how these new products should be labeled and tracked.

On the one hand, these cost-saving biosimilars will need to be clearly distinguished from their reference product so that regulators can track any adverse events and ensure they are safe, though on the other side of the coin, any new labeling requirements could lead to unwarranted safety concerns among physicians and patients, which would hamper uptake and mean higher costs.

For their part, industry groups Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) are showing no signs of letting up on their push to influence how biosimilars are named, particularly with their recent FDA petition outlining specific requests on what the labels should include.

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