- Reuters/Luke MacGregor
- The FDA on Friday approved a version of Herceptin, a blockbuster cancer drug used to treat breast and stomach cancer.
- The new drug, made by Mylan, is a type of medication called a “biosimilar,” which means it’s a copy of a medication made out of living cells, just as a copy of a chemical-based drug is known as a generic.
- Having more biosimilars in the US 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 FDA just approved a version of Herceptin, a blockbuster therapy used to treat breast and stomach cancer made by Genentech that made $6.7 billion in sales in 2016.
The newly approved drug, made by Mylan, will go by the marketed name Ogivri. It’s a type of medication called a “biosimilar.”
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. The FDA has approved a number of these drugs.
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 an antibiotic.
Having more biosimilars in the US 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 FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” FDA commissioner Scott Gottlieb said in a news release.
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. Some argue that the response to biosimilars entering the market has been disappointing so far, though.