New Interchangeable Biosimilar for Insulin Approved: What It Means for Diabetics

A new biosimilar product, the first one for insulin, has been approved by the Food and Drug Administration (FDA) as an “interchangeable” biosimilar. This interchangeable biosimilar for insulin is for adults with type 2 diabetes and children and adults with type 1 diabetes. The excitement here is around the fact that this product is expected to substantially reduce the cost of insulin for patients.

If you are interested in learning more about biosimilars, you can visit this…

Semglee (insulin glargine-yfgn) is biosimilar to the reference product Lantus (insulin glargine), which is a long-acting insulin. and is interchangeable with it. So, a pharmacist can substitute Lantus with Semglee without going back to the prescribing physician for approval—a pharmacy-level substitution. 

The FDA has developed a fact sheet that explains the concept of an interchangeable biosimilar product. While state laws have authorized pharmacists to substitute a brand-name product with a generic product at the pharmacy counter (this may vary by state), it has not been the same with respect to biosimilars. The biosimilar manufacturer has to apply for an interchangeable designation and provide sufficient data before the FDA approves the label. 

“Biosimilar Interchangeability” in plain English – by Jim

Will a Biosimilar Reduce Patients’ Cost Sharing for Insulin?

According to research published in 2020 by the RAND Corporation, the manufacturer price of insulin in the U.S. is dramatically higher than other developed countries, for both human and analog insulin. Below is the average price comparison for a standard unit of insulin (in 2018):

  • U.S.: $98.70
  • Japan: $14.40
  • Canada: $12.00
  • Germany: $11.00
  • France: $9.08
  • U.K.: $7.52

The study dug deeper into the cost of the various types of insulins based on their timing and found that rapid-acting insulin was the most expensive in the U.S. (2018, average standard unit price):

  • Rapid-acting insulin: $119.36
  • Rapid-intermediate–acting: $107.31
  • Short-acting: $87.20
  • Short-intermediate–acting: $95.05
  • Intermediate-acting: $73.56
  • Long-acting: $88.10

This is the manufacturer price of insulin, of course—also known as the list price—not what an insured patient would pay. What a patient will end up paying out-of-pocket varies depending on their insurance plan’s contract with the drug manufacturer—this information is very hard to gauge due to lack of transparency. Several studies have estimated what a patient might end up spending for their insulin (approximation):

  • $600 annually for privately insured
  • $23 annually for Medicaid
  • $1,288 annually for the uninsured

back to biosimilars

A majority of biosimilar products in the U.S. have been priced at a 15-35% lower list price compared to their reference product. However, Semglee has been listed at a 65% lower price compared to Lantus:

  • Semglee: $98.65/10 ml vial 
  • Lantus: $283.56/10 ml vial (2019 price)

The manufacturer of Semglee also offers a copay program for privately insured patients, which would take off up to $75 per 30-day prescription. At that price, Semglee might be a good option for uninsured or underinsured diabetes patients, or those who may not be able to participate in patient assistance programs.


Surabhi Dangi-Garimella

Surabhi Dangi-Garimella, Ph.D. is a biologist with academic research experience, who brings her skills and knowledge to the health care communications world. She provides writing and strategic support to non-profit groups via her consultancy, SDG AdvoHealth, LLC.

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