Judge rejects Amgen request to block Sandoz's copycat drug

Amgen loses first legal fight over Sandoz's biosimilar $AMGN

A federal judge rejected Amgen Inc.'s effort to temporarily block a competitor from releasing a copycat version of one of its top-selling biologic drugs.

The Thousand Oaks biotech company had accused Novartis subsidiary Sandoz of violating the law in its effort to sell a version of Amgen’s infection-fighting drug Neupogen in the United States.

U.S. District Judge Richard Seeborg in San Francisco declined to issue a temporary injunction against Sandoz, saying in a decision Thursday that Amgen had not shown that its competitor violated any laws in its efforts to bring the competing drug to market.

The Food and Drug Administration on March 6 approved Sandoz’s knockoff of the drug filgrastim, which Amgen has sold for more than two decades under the brand name Neupogen.

The FDA's decision was the first approval of a copycat drug, or so-called biosimilar,  in the U.S., a move set in motion in 2010 by Affordable Care Act provisions designed to cut the cost of biologics to patients.

Amgen said in a statement that it intended to appeal Seeborg’s ruling.

“We are disappointed in the district court’s decision and will seek review by the appeals court,” the company said in a statement.

Sandoz said it “welcomes the court’s decision and looks forward to introducing filgrastim as the first U.S. biosimilar.”

Sandoz intends to market the drug under the brand name Zarxio. It has sold it under the name Zarzio outside the U.S. for several years.

For decades, U.S. consumers have been able to buy cheaper generic versions of chemical-based pill medicines. Injected biologic drugs, Amgen’s specialty, had been exempt from that competition in the United States because they were not included in the landmark law that allowed the sale of generic chemical drugs.

Amgen’s arguments focused on technical analysis of the U.S. law governing biosimilars. It argued that Sandoz violated the law by failing to provide it with a copy of its FDA application and that it must wait six months before marketing the drug.

Sandoz said it is appropriate for an appeals court to resolve the issue.

“Given the importance of this case for future biosimilars, we agreed with Amgen before this hearing to jointly request expedited review of any appeal to the federal circuit,” Sandoz said in the statement.

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