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FDA approves first-ever generic version of insulin, which will dramatically cut costs

Posted at 1:55 PM, Jul 29, 2021
and last updated 2021-07-30 12:13:28-04

PHOENIX — In a win for consumers, the first-ever generic version of insulin has been approved for use, saving hundreds of dollars every month for people with diabetes.

The Food and Drug Administration approved the drug Semglee for sale in the U.S. last year but has now approved the drug to be labeled as "generic," lowering the cost significantly compared to brand-name insulin.

"It’s going to shake up the market, as you’d say. And we’ve been waiting for this," said Dr. M. Zuhdi Jasser with the Arizona Medical Association. "It’s time for the market to be working a little more robustly so they’re not able to make billions in profits on the backs of a lot of patients."

Semglee is a "biosimilar" drug, meaning it has no meaningful biological differences than what’s already been approved by the FDA.

"So just like you have Coke or Pepsi, now you have an additional soda available. Similar flavor, not the exact same structure but it does the exact same function for their blood sugar," said Dr. Jasser.

According to the Associated Press, depending on the pharmacy, Semglee injector pens cost about $150 to $190 without insurance for a one-month supply. Brand name, Lantus, costs $340 to $520 for the same supply.

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Acting FDA Commissioner Janet Woodcock, M.D. in a press release. “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

The FDA said more than 34 million people in the U.S. today have been diagnosed with diabetes, and in an effort to save those people money, biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.