On December 12, the U.S. Supreme Court declined to hear Apotex‘s case about whether biosimilar companies must wait six months following federal approval before bringing a biosimilar to market, an article in Reuters reports.
According to the article:
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 so-called biosimilar versions of California-based Amgen Inc‘s Neulasta, used to fight infection in cancer patients.
Makers of biologic drugs are given 12 years of exclusive rights under the biosimilar law before the U.S. FDA can approve a biosimilar. This law also states that the company producing the biosimilar must give the original biologic maker “180 days’ notice before launching its copycat version.”
Amgen argued that this 180-day period “cannot begin until the biosimilar is approved.” In July, the U.S. Court of Appeals for the Federal Circuit sided with Amgen, thereby preventing Apotex from launching its biosimilar until 180 days after the approval.
Amgen’s biologic, Neulasta, accounted for approximately $4.7 billion in sales in 2015 and was approved by the FDA in 2002.
According to the article in Reuters: “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”
But Apotex isn’t the only company that has applied to make a biosimilar version of Neulasta. Novartis AG’s Sandoz unit applied for both Neulasta and Amgen’s Neupogen, though neither application has been approved to date.