The Food and Drug Administration yesterday approved its first "biosimilar" drug — a lower-cost version of an expensive, complex medication — which could boost market competition and lead to billions of dollars in savings for insurers and patients.
"I think this helps promote innovation, and the companies will have to look for the next new product," said Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School. "This is how health care moves forward."
The drug, called Zarxio, was developed by Swiss pharmaceutical company Novartis and is modeled after Amgen's Neupogen, which increases white blood cells in patients receiving cancer treatments. Novartis has a research facility in Cambridge.
The medication falls into the category of "biotechnology" drugs, which are made from living cells.
A biosimilar differs from a generic, in that it's not a replica of the original drug, but it's close enough to be used in its place.
Zarxio is the first drug to gain FDA approval through the 351(k) pathway, a mechanism for biosimilars created in 2010 legislation.
This makes the approval a "historical moment," according to Kesselheim.
Dr. Andreas Klein, assistant director of the bone marrow and cell transplant program at Tufts Medical Center, said the hospital charges about $350 for each dose of Neupogen, and that will likely be cut 15 to 20 percent.
"We're going to see a lot of these drugs coming, these biosimilars appearing," Klein said. "This proves that this pathway works. It opens a door and it shows to the manufacturers who want to get into the business that the FDA knows how to accept these drugs now."
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