WASHINGTON — In his recent public appearances, Food and Drug Administration Commissioner Scott Gottlieb has sounded a repeating note: drug prices are too high, and especially prices for complicated protein-based drugs called biologics.
The answer, he says, is in part encouraging generic biologics, called biosimilars, to enter the market. And one way in which the FDA can do so, Gottlieb told an assembled crowd of insurers at an industry conference earlier this month, is to set clearer standards for what these drugs have to prove to be considered equivalent — or interchangeable — to the originals.
The example of generics is helpful. Any pharmacist could dispense oxycodone on a prescription for OxyContin, because generic products can be substituted by pharmacists for the brand. But the same isn’t true for the handful of biosimilars on pharmacy shelves. None of the nine approved biosimilars are considered interchangeable with their corresponding biologic. That fact, the thinking goes, means fewer biosimilars get sold and less incentive for drug companies to make them.
Of course the makers of the innovator biologics aren’t on board. They are making $ hand over fist on these drugs, and until the pathway for biosimilars was established several years ago, they faced an unlimited future without competition except from other innovator biologics with the same indication. Ever since the pathway for biosimilars was established, the innovator brands have been investing a ton of $ and effort to install and reinforce barriers to blunt adoption when biosimilars competitors came to market. They are working every angle they can think of, and have been for years. So far it is working pretty well for them.
This is essentially a rock fight, and they will never give up. There’s way to much money at stake.
The bad photo choice for “FDA charts path forward for biosimilars — but drug makers aren’t all on board” story calls into question your journalistic credibility. There are NO biosimilars in tablet form. They are all injectables!
not only is the pill photo a major blunder, but the example of generic substitution of non-biologics is also flawed. “Any pharmacist could dispense oxycodone on a prescription for OxyContin, because generic products can be substituted by pharmacists for the brand.”
Except there is really no generic form of OxyContin. Generic oxycodone is immediate-release/short-acting, so this not substitutable for long-acting oxycodone.
I agree that these sorts of mistakes erode confidence in the editorial credibility of STAT.