FDA's Biosimilars Guidance

The federal agency finally breaks out some information on what it might take to get generic biological drugs approved.

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FLICKR, STEVEN DEPOLO

The US Food and Drug Administration has unveiled its long-awaited draft guidelines on so-called "biosimilar" drugs, generics that mimic the action of biological drugs like enzymes and antibodies. Drugmakers have been anxiously anticipating guidance from the FDA as biologics patents expire and cheaper generic versions of biologics is a potentially huge market waiting to be tapped.

But in the three draft guidance documents, the FDA provided little specific information on what companies need to do to get biosimilars approved or on the "abbreviated approval pathway" mentioned in the Patient Protection and Affordable Care Act, signed into law by President Barack Obama in 2010. Instead, the agency indicated that it will instruct companies interested in developing such generics in specifics necessary to get their biosimilar products ...

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Meet the Author

  • Bob Grant

    From 2017 to 2022, Bob Grant was Editor in Chief of The Scientist, where he started in 2007 as a Staff Writer.
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