Judge Rules Apotex Must Wait 6 Months Before Marketing Neulasta Biosimilar
In an injunction, a federal judge has rejected Canadian drugmaker Apotex’s interpretation of federal law for biosimilars.
In a preliminary injunction issued last week, U.S. District Court Judge James Cohn concluded that Apotex’s plans to compete with Amgen for Neulasta’s (pegfilgrastim) market conflict with the Biologics Price Competition and Innovation Act. He applied the same legal standard as the law: Apotex must secure FDA approval to market the Neulasta biosimilar, inform Amgen and then wait six months before trying to market the product.
While Apotex interpreted the wording of “shall” in the statute to mean it is optional, both Amgen and the court viewed it as a mandate, leading the judge to impose the same requirements spelled out in the law.
“A statute must be interpreted as it is enacted, not especially in light of particular, untypical facts of a given case,” the judge wrote in his nine-page order.
He added that the six-month delay on marketing “will likely result in a more crystallized patent litigation,” since at least one of Amgen’s patents will likely expire before then.