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But in the three draft guidance documents, the FDA provided little specific information on what companies need to do to get biosimilars approved or on the "abbreviated approval pathway"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 approved—like the size and types of clinical trials—on a case by case basis.
"I don't think [the FDA] gave much guidance," D'vorah Graeser, patent agent at Chicago and Israel-based law firm Graeser Associates International, told Nature. Companies launching into the biosimilars game "may be rejected and have to go back to the drawing board several times," she added.
But the FDA may eventually roll out more guidance documents, providing more details. "We're not sure," Rachel Sherman, director of the office of medical policy in the FDA's Center for Drug Evaluation of Research, said at a press conference last week. "At the moment we're trying to get the most bang for our buck and cover the most territory possible, and going crack-by-crack does not seem to be the way to do that."