The FDA has just approved the first biosimilar for the US. These are drugs which are similar but not identical to the original patented drug. Amgen defines them as:
"Unlike generic medicines where the active ingredients are identical, biosimilars
are similar to but not identical copies of the originator biologic.
They are similar, but not the same. Biologics made by different
manufacturers differ from the original product and from each other."
The first FDA approved biosimilar is Zarzio, which is a biosimilar for Neupogen - the lovely injection many of us got after each chemo infusion to help ward off infections. But not to be confused with Neulasta. This first drug could add up to $6 billion over the next ten years.
"Zarzio’s introduction — primarily as a competitor to the Amgen
blockbuster Neupogen — marks a milestone, and could add up to savings of
$6 billion over the next 10 years, according to drug benefit manager
Express Scripts. But that’s just the start — Express Scripts estimates that if
11 other biosimilars pass muster with the FDA, they would shave $250
billion off spending on comparable existing biotech drugs over that same
So as big pharma comes up with these fancy new drugs at sky high prices, upwards of $100,000 per patient per year, which overwhelm the insurance companies, the new biosimilars can cut the market prices by 40-50%, which is not as much as the 70-80% savings with a generic.
I realize that biosimilars and generics are not for everyone but a little competition is good for the industry. Insurance companies can use the availability of a biosimilar to negotiate lower pricing for the original drug and shift many patients to the biosimilar to help with substantial savings.
I welcome these changes as a significant step to help contain medical costs.