WASHINGTON — The US Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs — known as biosimilars — to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies.
The justices, in a 9-0 ruling, overturned a lower court decision that had prevented Swiss pharmaceutical company Novartis from selling its copycat version of California-based Amgen’s Neupogen until six months after the U.S. Food and Drug Administration approved it.
Biosimilars are a bit more complicated than your average competing medicine: Unlike generics for chemical-based drugs like antibiotics that can be interchangeable with branded versions, the copycats of biologic medications, produced using living cells, have a few more caveats.
As it stands right now, biosimilars can’t be used interchangeably with branded versions, meaning if you were to get a prescription for a branded biologic, you wouldn’t be able to opt for the “generic” one at the pharmacy as easily as you could if the drug was, say, a statin.
It also takes more time, energy, and money to get a biosimilar approved, compared to a generic medicine. To develop a biosimilar, it usually takes about eight years and can costs about $250 million. In comparison, a generic takes a quarter of that time (about two years) and costs a tenth of the price ($5 million) to produce.
Having more biosimilars on the market faster — without waiting six months — would be a big deal. It might be the best way to drive down the cost of biologic medications that have been around for a while. The savings of putting people on far less costly biosimilars — even just new patients who have never taken the original — are estimated to be billions of dollars. Express Scripts, a pharmacy benefit manager, estimated in 2013 that the US could be saving $250 billion over the next 10 years because of biosimilars.
Reuters reporting by Andrew Chung.