Court Delays U.S. Sales Of First Biosimilar Drug

Sales of the first generic-like version of a biological drug, or biosimilar, in the U.S. are on hold until a lawsuit between rival companies can be resolved.

In a case filed by Amgen, a federal appeals court earlier this month temporarily blocked Novartis’s Sandoz from selling a biosimilar called Zarxio. It is a less expensive alternative to Amgen’s Neupogen (filgrastim), a blockbuster drug prescribed to prevent infections in cancer patients.

Amgen is fighting to keep Zarxio off the U.S. market, claiming that sales of the knockoff drug would erode the price of Neupogen and cause other irreparable and immediate harms. In its lawsuit, Amgen argues that the launch of Zarxio would undermine the value of its patents. Novartis did not provide Amgen with the information it needs to determine whether Zarxio infringes on its patents, asserts the maker of Neupogen.

Amgen is cheering the decision by the U.S. Court of Appeals for the Federal Circuit granting the company’s request for a preliminary injunction that prevents the sale of Zarxio. Novartis, on the other hand, says it hopes for a prompt resolution to the case so that it can begin selling Zarxio in the U.S. soon.

As part of the litigation, Novartis previously had agreed to delay the launch of Zarxio sales until May 11. The new ruling pushes back the U.S. debut of the biosimilar until at least June 3, when the court hears oral arguments in the case.

The litigation is being closely watched because its outcome will likely shape the future of the biosimilars market in the U.S. In March, Zarxio became the first biosimilar to successfully navigate the Food & Drug Administration’s new abbreviated approval process for biosimilars. FDA is reviewing at least four more applications for other biosimilar drugs.

Biosimilars have the potential to increase patients’ access to drugs that are prescribed less often because of their high prices, according to Louis M. Weiner, director of the Lombardi Comprehensive Cancer Center at Georgetown University. “The approval of Zarxio may reduce costs to the health care system,” he said when FDA approved the drug in March.