Cheap Insulin’s Next Battle Is With Entrenched Rebate System

The next hurdle for affordable insulin in the U.S. will be navigating the convoluted rebate and insurance system after the FDA simplified the process for approving cheaper alternatives, analysts said.

The goal is to break up the dominance of Eli Lilly, Novo Nordisk, and Sanofi in the insulin market, which has led to steep prices. To that end, the Food and Drug Administration starting March 23 will classify insulin with other complex drugs made from living cells and proteins, which are known as biologics.

That should make it easier for companies that want to develop cheaper alternatives, called biosimilars. ...