High court ruling speeds up generic biotech drug approval
The Supreme Court is speeding up the time for generic biotech drugs to become available to the public. The court's unanimous ruling Monday means a loss of billions in sales to makers of original versions.
The justices ruled in favor of generic drug maker Sandoz in its dispute with rival Amgen over a near-copy of Amgen's cancer drug Neupogen.
The case involves biologics—drugs made from living cells instead of chemicals. The drugs have led to major advances in treating diseases, but come at steep prices.
A 2010 law allows cheaper generic versions known as biosimilars to be produced after a 12-year exclusive run for the original.
The court said companies making biosimilars don't have to wait an extra six months after gaining federal approval before selling the drugs.
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