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.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!


What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • Online intelligence briefings
  • Frequent opportunities to engage with veteran beat reporters and industry experts
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.
  • 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.

Comments are closed.

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy