WASHINGTON (Reuters)—The U.S. Supreme Court on Monday declined to hear a case over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval before bringing them to the market.
The justices opted not to take up Apotex Inc.’s appeal of a July federal appeals court ruling that could delay the Canadian generic drug maker’s launch of biosimilar versions of California-based Amgen Inc’s Neulasta (pegfilgrastim), used to fight infection in cancer patients.
Approved by the U.S. Food and Drug Administration (FDA) in 2002, Neulasta is one of Amgen’s top-selling products, accounting for $4.7 billion of its nearly $21 billion in sales last year.
Biologic drugs, such as Neulasta, are made using living cells. Unlike traditional drugs, biologic drugs cannot be copied exactly to make generic versions. A 2010 federal law, the Biologics Price Competition and Innovation Act, allows companies to seek approval to sell near-copies, called biosimilars.