The U.S. Supreme Court on Monday ruled drugmakers will no longer have to wait six months after regulatory approval to launch new biosimilar drugs, reports Reuters.
Here are four things to know.
1. The court voted 9-0 to overturn a lower court's ruling blocking Novartis' subsidiary Sandoz from selling Zarxio — a biosimilar version of Amgen's biologic drug Neupogen — until six months after receiving Food and Drug Administration approval.
2. The ruling ends a three-year patent dispute between Amgen and Sandoz, which centered on an ACA provision that said a biosimilar drugmaker must give the brand name drug company 180-days notice before launching a copycat version, according to Reuters. Amgen argued the 180-day notice must come after FDA approval, while Sandoz said this practice would give Amgen an additional six-month exclusivity period.
3. Zarxio — the first biosimilar ever approved by the FDA — cost 15 percent less than Neupogen before it was pulled from the market amid the patent dispute. Michael Alkire, COO of Premier, believes the Supreme Court's ruling will help achieve lower drug costs for patients using biologic drugs.
"With this decision, the Supreme Court has effectively closed a competitive loophole that allowed branded companies an additional six months of market exclusivity, and delayed the competitive entrance of biosimilars that have been shown to lower pharmaceutical costs," he said in a statement emailed to Becker's.
4. Novartis said the ruling "will help expedite patient access to life-enhancing treatments," according to a statement cited by Reuters. Amgen spokeswoman Kelley Davenport told the publication the drugmaker was disappointed but "will continue to seek to enforce our intellectual property against those parties that infringe upon our rights."
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