The Food and Drug Administration wants to make it easier for makers of generic copies of complex therapies, particularly those that use devices to deploy the active ingredient, to bring their products to the U.S. market, the head of the agency said.
The move may help generic companies that are seeking to compete with products like Mylan NV's emergency anaphylaxis medicine EpiPen or GlaxoSmithKline plc's asthma drug Advair Diskus, whose complex delivery devices have kept rivals at bay.
The active ingredient a generic company is seeking to market may be an older drug, but the branded manufacturer may still hold the intellectual property protection on certain features of the device, creating a hurdle to approval for the lower-cost product, FDA Commissioner Scott Gottlieb said Nov. 28 during remarks at the agency's Generic Drug Science Day.
So generic competitors must develop devices that work similarly to deliver the drug but have differences that allow the companies to avoid infringing the innovator products' patents.
Such a strategy, however, may raise complicated scientific and regulatory questions about whether the generic therapy will have the same clinical effect and safety profile and thus be substitutable for the branded drug product, Gottlieb said.
To address those concerns, the FDA is working to complete new guidance that would allow a generic product to have certain labeling differences from the branded therapy, "if such labeling changes stem from permitted design differences," the agency chief said.
"Under this guidance, as long as the generic applicant is able to demonstrate with data, where appropriate, that differences in the design of the generic product do not affect the clinical effect or safety profile when the generic is substituted for the branded product, the generic product can be approved as a competitor to the branded drug where all other requirements for generic approval are met," Gottlieb said.
"We have taken steps to provide industry with greater guidance on the types of information and analyses generic sponsors that want to copy a branded product, like an auto-injector or a metered dose inhaler, should submit to FDA to support approval of such products, even when the generic versions have some design differences relative to the branded drug they're copying," he said. "And those design differences might correlate with different instructions for use of the two products."
Gottlieb did not provide a timeline for the release of the guidance.
Clarifying 'sameness' requirements
The FDA also is working to develop guidance for the industry with the aim of clarifying "sameness" requirements for generic applications. "We believe that guidance in this area may be particularly helpful for complex generics, including drug-device combination products," Gottlieb said.
He said the FDA also has committed to putting out guidance that would lay out how a generic company could copy a particular complex drug at least two years in advance of the first potential generic entrant.
"This will make it easier for generic firms to plan how they can copy complex drugs," Gottlieb said.
Gottlieb noted he has been focused on other ways to speed generics to the market, including taking actions to prevent brand-name drugmakers from gaming the system.
Earlier this month, he told innovators attempting such feats that it was time to "end the shenanigans."
In June, the FDA published a list of brand-name medicines whose patents and exclusivity protection periods have expired and for which there are no generic challengers, with the aim of shedding light on areas that need more competition.
"By proactively listing these drugs, and making clear that we'll expedite approval of any application for one of these medicines, we'll be helping to reduce the financial incentive to play games with these drugs," Gottlieb said at the Nov. 28 FDA generics conference.