Here's a hypothetical: What happens when the FDA grants exclusivity to a new drug ingredient that isn't exactly new?
Novartis' generics unit claims the agency did just that with Sanofi's multiple sclerosis med Aubagio—but the dispute isn't necessarily just about the New Chemical Entity (NCE) exclusivity itself. That's no longer in force according to the FDA Orange Book. It's also about the 180-day exclusivity drugmakers win when they're first to file for copycat approval—and right now, 20 generics are poised to hit the scene simultaneously in 2023.
Sandoz has already petitioned the agency two times, arguing that Sanofi didn't deserve NCE status for Aubagio. Now, it's suing the FDA for the "unlawful award" and for the agency's refusal to accept Sandoz's first application for a copycat version.
If the court doesn't force the FDA to accept that early app, it could cost Sandoz the coveted 180-day exclusivity, when one generic rules the market, prices are higher and competition from other copycats nil, the lawsuit claims.
The lawsuit itself says that a six-month lock on the market is worth $100 million to Sandoz. And the NCE argument is key to whether the generics unit deserves it because a generics maker can file for approval a week ahead of the typical date—if they believe an NCE wasn't properly granted, that is.
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To win NCE status—essentially, to be called a brand new, innovative drug—the med's active ingredient must be new. Aubagio's active ingredient is teriflunomide—a new substance—but the molecule was known to be effective against autoimmune diseases such as MS "long before" Sanofi filed Aubagio for approval, the lawsuit claims.
The FDA itself knew this, the lawsuit states. Since 1998, Sanofi has sold a rheumatoid arthritis drug, Arava, whose active ingredient is leflunomide. That ingredient is metabolized in the body to become teriflunomide, "which is responsible for essentially all of leflunomide’s in vivo activity,” Arava's FDA label states, as cited by the lawsuit.
FDA itself has said that teriflunomide "was well understood" by the agency ahead of Aubagio's approval and that, for all intents and purposes, the drug is "equivalent" to Arava, the lawsuit claims.
In August 2016, the company formally challenged the FDA's NCE award to Aubagio. It followed up with two Abbreviated New Drug Applications (ANDAs) for its generic version on September 7 and September 12, 2016—the date when companies were allowed to file copycats under the period of NCE exclusivity.
A slate of other generics makers did just that on September 12, 2016. And now, unless the court tells the FDA to accept Sandoz's September 7 application, it will be vying for market space alongside 20 other generic applicants when Aubagio generics launch.
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Sandoz lost its first petition to the FDA. It appealed and lost again. Hence the lawsuit, which argues that the FDA's stance undermines the purpose of NCE exclusivity, which is to promote development of previously unapproved therapeutic molecules. "[T]hat, after all, is what makes them new," the lawsuit states. Instead, the FDA gave Sanofi a "windfall renewal of NCE exclusivity" for an ingredient approved years back in Arava, Sandoz claims.
"NCE exclusivity is an important incentive for the discovery and development of new therapeutically beneficial molecules," Leslie Pott, communications VP at Sandoz, said via email. "However, where it is awarded improperly to a molecule that is not new, challenging such an award is a critical part of ensuring that affordable generic alternatives can be brought to the market in a timely manner," she continued.
Meanwhile, Novartis' branded multiple sclerosis blockbuster, Gilenya, is set to face generic competition of its own later this decade. In December 2019, the FDA tentatively approved the first three generic versions of the drug, made by HEC Pharm, Biocon and Sun Pharmaceutical, though they won't be hitting the market immediately. In June of that same year, the U.S. Patent Office issued a ruling that protected the branded version of Gilenya until 2027.
Editor's note: This story has been updated with comments from Sandoz.