The price of insulin, a life-saving treatment discovered a century ago, has been a flashpoint amid the broader drug pricing debate. The FDA is trying to tame high insulin prices by encouraging price competition.
The FDA has historically regarded insulin as a drug. But insulin isn’t a chemical drug, it’s made from biological material. Under a rule change published this week, the FDA will classify insulin as a biological product. When the change takes effect on March 23, would-be competitors will be able to seek approval for products that are biologically similar to the branded insulin now on the market, the… Read more »
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