Court Battles

Supreme Court rules to speed marketing of lower-cost ‘biosimilar’ drugs

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Manufacturers of copycat “biosimilar” medical products will be able to bring their drugs to the market faster after a unanimous U.S. Supreme Court decision Monday.

The court in Sandoz v. Amgen ruled 9-0 in favor of generic drugmaker Sandoz in a dispute with rival company Amgen. The court ruled that manufacturers of low-cost biosimilars don’t need to wait an extra six months after FDA approval to launch their product. The ruling is expected to save consumers — and the U.S. health system — billions of dollars.

Sandoz is the generics arm of the drug company Novartis.

{mosads}Sandoz argued against a lower court’s ruling that prevented them from selling a biosimilar version of Amgen’s drug Neupogen until six months after the Food and Drug Administration approved it. Sandoz’s drug costs about 15 percent less than the brand name. Biologic manufacturers already have 12 years of market exclusivity, and Sandoz argued that the ruling essentially gave Amgen an additional six months, which could cost them millions in sales.

The decision is a huge victory for other biosimilar manufacturers. Biologics are an ever-increasing share of the U.S. drug market. They are made from living cells instead of chemicals and, as a result, they can’t be copied to make generic versions. But while they’ve helped advance disease treatments, they can be expensive.

A provision of the Affordable Care Act requires a biosimilar manufacturer to give the brand-name manufacturer 180 days notice before launching. A federal appeals court in 2015 ruled that the 180-day notice must be given only after FDA approval.

Writing for the Court, Justice Clarence Thomas reversed that decision.


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