Amgen Inc. and Novartis AG battled in a Washington appeals court Wednesday over when a copycat version of Amgen’s cancer treatment Neupogen can be sold in the U.S., in the first case of its kind.
Arguments before the U.S. Court of Appeals for the Federal Circuit centered on how to interpret a 2010 law that created a path to approve copies of biologic drugs that are based on living organisms. The copies are known as biosimilars. The court gave no indication when when it would rule, but it’s been on a fast track so a decision could come in weeks.
A ruling is “integral to how the regime is going to work going forward,” Amgen lawyer Nick Groombridge of Paul Weiss in New York told the three-judge panel.
At issue is whether Sandoz followed U.S. Food and Drug Administration rules when it sought approval for its version of filgrastim, the active ingredient in Neupogen. Regulatory approval for the drug in March was hailed as the beginning of cheaper consumer access to bioengineered treatments for serious illnesses like cancer and arthritis.
Sandoz should be allowed on the market now, or Sept. 2 at the latest, said Sandoz lawyer Deanne Maynard of Morrison & Foerster in Washington.
One difficulty is that the 2010 law for biosimilars is different from a three-decade old statute that sets out the steps for getting approval for generic versions of chemical-based drugs. The earlier law includes rules on how litigation should proceed and has been interpreted by courts for two decades. The newer law doesn’t have that history.
“If the purpose of the legislation is to avoid litigation, it failed,” Circuit Judge Alan Lourie told the full courtroom.
“It’s hard to make sense of the extensive legislative debate” over certain provisions, Circuit Judge Pauline Newman said.
Sandoz has been barred from selling its copy, called Zarxio, until the court decides the case. The law authorizing the FDA to approve the copycats passed Congress in March 2010 but regulators took years hashing out the steps to get biosimilar approval.
Unlike a true generic drug, which is basically duplicating the molecular structure of the name-brand drug, developing a medicine based on a living organism involves greater testing and advanced manufacturing skills.
Neupogen, approved by U.S. regulators in 1991, is a therapy to help increase cancer patients’ white blood cell counts and fight infections. It costs $3,000 for each chemotherapy cycle, a figure that Amgen said doesn’t take into account discounts, rebates and other price concessions. The price depends on the patient’s weight and dose ordered by the doctor, the company said.
The drug generated $839 million in U.S. sales last year for Amgen. Sales have been falling as patients switched to a newer version of the drug, called Neulasta. Kelley Davenport, a spokeswoman for the company, said Amgen was “confident in the merits of our appeal.”
Since it’s the first case of its kind, a decision by the court will provide guidance for other would-be makers of biosimilars. They include Celltrion Inc., which is seeking to make a copy of Johnson & Johnson’s arthritis drug Remicade.
The litigation has been on the fast track -- the trial judge issued his ruling that would have let Sandoz on the market in March and the Federal Circuit issued an order to prevent sales in May. The speed with which the case is moving indicates a decision could come within weeks rather than months.
The case is Amgen Inc. v. Sandoz Inc., 15-1499, U.S. Court of Appeals for the Federal Circuit (Washington).