The U.S. Supreme Court issued a 9-0 ruling today that will have the effect of speeding the process for biosimilars going to market.
The court overturned a lower court's decision, ruling that makers of biosimilar drugs will no longer have to wait six months after U.S. Food and Drug Administration (FDA) approval before going to market with those drugs.
The case, Sandoz v. Amgen, involved a complaint filed by generic pharmaceutical company Sandoz, a division of Novartis, which argued against a lower court ruling that prevented Sandoz from selling a biosimilar version of the Amgen-made drug Neupogen until six months after FDA approval.
The majority opinion, authored by Justice Clarence Thomas, can be read in full here.
The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, praised the court's decision.
“The Supreme Court’s ruling on biosimilars will help create more competition among costly biologic medications, which is the key to reducing overall prescription drug costs for consumers, employers, government programs, and others," said PCMA in a statement.
The ruling could have the impact of saving consumers billions of dollars. A 2013 study released by pharmacy benefit management company Express Scripts, found that the U.S. could save $250 billion over the next decade due to biosimilars.
Alerts Sign-up