When the controversy over the cost of the EpiPen exploded late last summer, many consumers asked why there was no substitutable generic variation available.
The answer was complex: while the key ingredient from the anaphylaxis treatment, epinephrine, has been available for decades along with will be no longer covered by a patent, the delivery device proved hard for generic competitors to copy to a degree in which would likely satisfy regulators.
Tuesday, the Food along with Drug Administration announced guidance seeking to change in which, potentially streamlining a path to market for generic copies of complex medicines like the EpiPen along with others.
The FDA guidance says in which generic copies with some design differences may be approved as substitutable products, as long as those differences don’t affect patients’ ability to use the product the way in which’s intended.
“Those design differences might correlate with different instructions for use of the two products,” the agency’s commissioner, Dr. Scott Gottlieb, said in remarks at the FDA published Tuesday morning.
“Under This particular guidance, so long as the generic applicant will be able to demonstrate with data, where appropriate, in which differences in design of the generic product do not affect the clinical effect or safety profile when the generic will be substituted for the branded product, the generic product can be approved as a competitor to the branded drug where all different requirements for generic approval are met,” Gottlieb said.
The agency will be also seeking to clarify guidelines on what constitutes “sameness” between generic along with branded medicines.
The FDA didn’t mention any drug or therapeutic class by name, referring to a category of complex generics in which includes medicines delivered through devices like metered dose inhalers, or auto-injectors.
The move comes as Gottlieb has acted on President Donald Trump’s directive to bring drug prices down, mainly by increasing generic competition.
There are different epinephrine auto-injectors already on the market competing with the EpiPen, which will be made by Mylan, such as Impax Labs’ Adrenaclick. None possess the dominance or name recognition of the EpiPen, along with cannot be directly substituted at pharmacies when doctors write prescriptions for EpiPens.
Teva had sought to bring a direct generic competitor to the EpiPen to market, nevertheless said in early 2016 in which its product was rejected by the FDA for “certain major deficiencies.”
In response to criticism over the cost of the EpiPen, Mylan introduced its own generic variation at half the cost. in which’s an identical variation of the product without the same branding.
Gottlieb said the goal of the brand-new guidance “will be to promote generic entry as a way to foster cost competition, along with improve access to healthcare.”
The FDA, he said, has “committed to put out guidance laying out how a generic firm would likely copy a particular complex drug at least two years in advance of the first potential generic entrant.”