A federal judge has denied a bid by Sanofi-Aventis to halt sales of a generic version of its blockbuster blood thinner Lovenox, a move which may help pave the way for the Food and Drug Administration to approve generic biologic drugs.
In a 33-page opinion issued last night, Judge Emmet Sullivan of U.S. District Court for the District of Columbia found Sanofi failed to show the FDA had acted unreasonably in approving an application by Sandoz Inc. to make generic Lovenox. He denied Sanofi’s request for a preliminary injunction that would have forced the FDA to rescind approval of the generic, which has been on the market for a month.
“Just because the FDA – after seven years of careful consideration …reached a conclusion at odds with the position advanced by Sanofi, does not mean that the FDA’s decision was arbitrary and capricious,” Sullivan wrote, adding that the court “finds it unlikely that Sanofi will succeed on the merits of its claims.”
Still, Sanofi is not giving up on the fight. “The Court has not ruled on the merits of the company's suit against the FDA,” Sanofi said in a statement. “The company's case against the FDA will continue to move forward, even without preliminary injunctive relief. Sanofi-Aventis believes that this case poses a number of significant questions regarding the FDA review process for complex pharmaceutical products which are important to pursue.”
Lovenox, which had domestic sales of $2.5 billion last year, is derived from pig intestines. It’s not technically classified as a biologic drug – a complex medicine derived from living organisms – but it’s similar.
The FDA is currently formulating guidelines for approving generic biologics. Amicus curiae AARP flagged the Lovenox case as a potential precedent for bringing generic biologics to market, and urged the court to back the FDA and Sandoz.
Sanofi, represented by Emily Henn of Covington & Burling, argued that the FDA overstepped its authority by asking Sandoz to perform additional safety tests before granting approval on July 23.
The tests were to determine whether impurities in the generic version of the drug could trigger a potentially deadly immune reaction at a higher rate than the brand name.
Sullivan concluded that the tests were “both reasonable and consistent” with FDA authority.
Sanofi also protested that the FDA ignored its own precedent by approving a generic that was not “fully chatacterized” – that is, scientists have not been able to identify all of the structures within the drug, a feat that is not possible using today’s technology.
The agency’s decision to approve the drug, Sullivan wrote, was “based on the evaluation of complex scientific information within the agency’s technical expertise,” and entitled to deference by the court. He also rejected Sanofi’s argument that the FDA erred in finding the generic had the same active ingredient as Lovenox.
Nor was the judge persuaded that Sanofi would suffer irreparable harm without an injunction, noting that Lovenox sales represented just 6% of the company’s overall revenue in 2009. At the same time, Sullivan acknowledged that injunction would hurt Sandoz, both in customer good will and lost sales (Sandoz expects generic Lovenox sales of more than $40 million in the next six weeks).
“Whatever sales Sanofi will lose to Sandoz in the absence of an injunction, Sandoz will lose to Sanofi in the presence of one,” he wrote, adding that the court “concludes that the public would be harmed by a court-ordered delay in the distribution of a generic drug that is approximately 30-35% cheaper than Lovenox.”
Sandoz was represented by Robert Milne of White & Case and William Schultz of Zuckerman Spaeder, while the FDA was represented by Department of Justice senior litigation counsel Andrew Clark.