- The Food and Drug Administration has blocked Allergan's latest attempt to stave off generic competition to Restasis, rejecting a citizen petition filed by the company last August that challenged the regulator's approach to approving copycat versions of the blockbuster eye drug.
- Allergan's petition, its third for generic Restasis, questioned whether competitors could use in vitro testing to adequately demonstrate bioequivalence with the branded product. Draft guidance from the FDA would allow generic companies to use either in vitro or in vivo testing to secure approval of Restasis copies.
- Losing protection for Restasis is no small matter for Allergan. The drug brought in an estimated $1.4 billion in sales last year and is particularly profitable for the pharma, with margins around 80%.
While a drugmaker seeking to delay generics is nothing new, Allergan has been both persistent and inventive in trying to shield Restasis.
The pharma previously filed substantively similar petitions to the FDA in February and December of 2014, both of which were denied. Each submission, including the most recent one, focused on whether in vitro testing would be able to appropriately determine whether a proposed copy would be identical to Restasis. The most recent denial, issued by the FDA on Jan. 3, was first reported by Regulatory Focus.
"FDA has stated its desire to approve ANDAs for products that claim to be bioequivalent to Restasis, without any need for human clinical confirmation," Allergan argued in the August petition. "However, the evolving in vitro approaches that the Agency has described over the course of multiple revised draft guidances are built upon circular logic and inconsistent statements, as well as lacking fundamental data to define and support this approach."
Filing petitions hasn't been Allergan's only tactic, either. In September 2017, the company announced that it would sell all Orange Book-listed patents covering Restasis to the St. Regis Mohawk Indian Tribe, who then licensed those same patents back to Allergan. The unusual move was aimed at circumventing a type of legal challenge called inter partes review by tapping the Tribe's sovereign immunity.
But the inventive strategy, which sparked widespread criticism, might not do much to protect Restasis after all. A subsequent October ruling by a federal district court judge invalidated four key patents covering the drug, opening it to generic threats.
Mylan NV, a generic competitor developing a copy to Restasis, urged the FDA to reject Allergan's petition — even citing the Irish pharma's patent deal with the Mohawk tribe in a bit of intra-industry sniping.
"Through these serial petitions and other antics, such as trying to avoid inter partes review of its patents before the Patent Trial and Appeal Board through a sham transaction with a Native American tribe, Allergan is engaging in an overarching anticompetitive scheme to impede early access to generics," wrote Carmen Shepard, Mylan's head of global quality and legal regulatory, in a Dec. 22 comment on Allergan's citizen petition.
The FDA's denial of Allergan's citizen petition appears to ink the writing on the wall. The company has already booked a $3.2 billion impairment charge related to Restasis and is preparing to mitigate any blow to its bottom line.
"This business will generate significant cash flow even if we were to lose Restasis, and we will deploy that cash flow to create value for our shareholders," Allergan CEO Brent Saunders said in a third quarter earnings call.