Supreme Court Declines Biosimilar Patent Dispute Save

The U.S. Supreme Court has declined to hear a case over whether companies that make biosimilar drugs must wait six months after federal approval before they bring them to the market.

Specifically, the declined the petition by Apotex (against Amgen) arguing that Apotex should not have to wait 6 months after its biosimilar of the Amgen product is FDA approved. Current law requires the biosimilar manufacturer to give 180 days notice to brand-name manufacturer (Amgen) about its marketing plans.

This decision also affects Sandoz's Zarxio (the first approved biosimilar of filgrastim). 

Apotex manufactures a biosimilar version of Amgen's Neulasta (filgrastim).Neulasta (approved in 2002) sold  $4.7 billion worth of the drug just last year.

The current biosimilars law gives the maker of a biologic drug 12 years of exclusive rights before the U.S. Food and Drug Administration can approve a biosimilar. It also states that a biosimilar maker must give the original biologic drug maker 180 days' notice before launching its biosimilar version into the market.

Amgen has argued that the 180-day period cannot begin until the biosimilar is approved. The U.S. Court of Appeals for the Federal Circuit agreed in July, barring Apotex from launching its biosimilar until 180 days after approval.

In its petition asking the Supreme Court to review that decision, Apotex said the Federal Circuit wrongly added an extra six months to the law's 12-year exclusivity period.

t also argued that it should be exempt from the 180-day notice requirement entirely, because it voluntarily took part in a patent dispute resolution process under the biosimilars law.

A federal judge in Florida rejected patent infringement claims by Amgen over Apotex's biosimilars in September.

The Obama administration's solicitor general has weighed in on a Supreme Court petition from Sandoz unit in its similar dispute with Amgen, coming down against the 180-day wait.