[Editor’s Note: This post has been updated to include comments from Rita Kalyani, MD.]
When the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product last month, many were hailing this as a breakthrough in treating diabetes. The impacts could be immediately felt by people rationing their insulin due to cost as well as long-range effects on future clinical trials.
Last month, the U.S. Food and Drug Administration (FDA) approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes. The FDA granted approval for insulin glargine-yfgn to Mylan Pharmaceuticals Inc., who is marketing the product as Semglee.
Semglee (insulin glargine-yfgn) is both biosimilar to and interchangeable with its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee is the first biosimilar product to get the “interchangeable” designation in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality, and potentially cost-effective options for treating diabetes.
An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution” — much like how generic drugs are substituted for brand-name drugs, subject to state pharmacy laws, which vary by state.
“It may allow people who have been rationing their insulin because of cost to stop doing so. This would improve glycemic control in those who are doing so. I think it will also change the design of trials of new insulins so that they can be designated as both biosimilar and interchangeable.” — Robert Vigersky, chief medical officer, Medtronic; director emeritus, Diabetes Institute,Walter Reed National Military Medical Center, Bethesda, Md.; past-president, Endocrine Society
“Biosimilar and interchangeable biosimiliar insulin products have the potential to lower costs for patients. Hopefully, this approval will help drive prices down for insulin in the long term. Access to affordable care, and particularly affordable insulin, is a priority in diabetes care,” says Rita Kalyani, MD, associate professor at Johns Hopkins School of Medicine in Baltimore. “From a patient perspective, this can help increase access to less expensive alternatives from the pharmacy. However, there will be some individuals that still prefer the brand insulin and there will need to be more education going forward that these two products are, in fact, interchangeable. “
And while on the surface this looks like a wonderful announcement and something that many endocrinologists have been waiting for years to hear, as Irl Hirsch, MD, professor of medicine at the University of Washington Diabetes Institute in Seattle, tells Endocrine News, the devil is in the details. Semglee currently costs around $100 per vial, and while that’s much cheaper than Lantus, that’s still a hefty price tag, especially when you consider Canadians pay around $30 a vial.
“A bigger concern is whether the [pharmacy benefit managers] will be incentivized not to provide the biosimilar insulin to patients — due to contracting with the pharmaceutical company,” Hirsch says. “Since this is interchangeable by the pharmacist, this means the pharmacist will have the discretion not to use the cheaper insulin. Admittedly, this is the worst-case scenario, but this is the reason why both clinicians and patients need to be familiar with this new ruling to ensure the best value for this insulin.”
“For biosimilars to have an impact on the price of insulin, availability must extend beyond current manufacturers and new companies must be willing to undertake a costly development and strict review process.” — Endocrine Society Position Statement, “Increasing Insulin Affordability.”
There will be some things to iron out — patient and doctor confusion, hesitancy to change medications, etc. — but the hope is that this approval will pave the way for more interchangeable biosimilars to enter the market and drive prices down. The approval of this new biosimilar is in line with the Endocrine Society’s Position Statement from January, “Increasing Insulin Affordability.” Before Semglee, there were only two biosimilars available, made by Eli Lilly (Basaglar) and Sanofi (Admelog), two of the three insulin manufacturers. “For biosimilars to have an impact on the price of insulin, availability must extend beyond current manufacturers and new companies must be willing to undertake a costly development and strict review process,” the Position Statement authors write.
“This will undoubtedly continue the increase the downward pressure on insulin pricing,” says Robert Vigersky, MD, chief medical officer at Medtronic, director emeritus of Diabetes Institute at Walter Reed National Military Medical Center in Bethesda, Md., and past-president of the Endocrine Society. “Most importantly, it may allow people who have been rationing their insulin because of cost to stop doing so. This would improve glycemic control in those who are doing so. I think it will also change the design of trials of new insulins so that they can be designated as both biosimilar and interchangeable.”