Federal Court Denies Injunction Against FDA Approval of Biologic-like Generic Drug

The Ruling

The U.S. District Court for the District of Columbia was unpersuaded by Sanofi's argument that an injunction is needed, ruling in Sanofi-Aventis v. FDA et al. that the tests for an injunction require a very high showing that Sanofi did not meet.

Among other things, the court found that the public would be harmed by a court-ordered delay in the distribution of a generic drug that is approximately 30 percent to 35 percent cheaper than Lovenox. Citing AARP's amicus brief, the court concluded that Sanofi had failed to establish that the public interest favors interim injunctive relief.

As noted in The Wall Street Journal, "The Lovenox case is being closely followed by the drug industry because it hinges largely on the Food and Drug Administration's authority to set special standards for approving certain complex protein-based drugs. The decision could affect future FDA methods for approving generic biologic drugs."