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But in the three draft guidance documents, the FDA provided little specific information on what companies need to do to get biosimilars approved or on the "abbreviated approval pathway"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 ...
