How a 'regulatory dead zone' may be holding up copycat insulin

BioPharma Dive

14 January 2019 - The insulin market has increasingly attracted scrutiny from politicians, regulators and patient groups, as prices ramp higher for the hormone that millions of diabetics depend on to stay alive.

FDA head Scott Gottlieb has advocated for greater competition in the pharmaceutical industry as a means of bringing down drug costs. 

But, for insulin, changing legal rules have effectively created a "regulatory dead zone," hindering generic drug makers filing applications for copycat versions of the biologic drug.

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Michael Wonder

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Michael Wonder