Last summer, the U.S. Food and Drug Administration 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.
The FDA’s approval of the first insulin biosimilar, Semglee, provides a significant opportunity to lower costs while expanding life-saving treatment options for the millions of insulin-dependent Americans living with diabetes. The approval is significant for a multitude of reasons — not only is Semglee the first interchangeable biosimilar, but also the first biosimilar that is primarily dispensed at retail pharmacies.
While this empowers retail pharmacists to play a key role in influencing biosimilar adoption, a new survey by Cardinal Health found only about 40% of retail pharmacists feel very prepared to discuss biosimilars with patients. In addition, only 20 % say they are very familiar with the FDA’s interchangeability designation, which enables them to substitute insulin biosimilars in place of reference biologics, indicating a significant need for further education among pharmacists. The results of this survey were published recently in Biosimilars Report: The U.S. Journey and Path Ahead.
Currently, there are about 30 FDA-approved biosimilar medications in the U.S. Semglee is the first biosimilar insulin, and the hope is that more will make it to market and drive the cost of insulin down. In the Diabetes Trends section of the biosimilars report, Chevon Rariy, MD, vice president and chair of Virtual Health at Cancer Treatment Centers of America and medical director of Endocrinology, writes: “In our survey, most pharmacists were comfortable substituting a biosimilar for a reference product if it would deliver lower out-of-pocket costs for the patient, but they expressed concern about both the efficacy of biosimilars and a lack of payer adoption in this substitution. While it is true that interchangeable biosimilar insulin products like Semglee could potentially provide cost-effective, safe treatment options for patients with diabetes, providers agreed that payers and PBMs have the most influence in shifting utilization to insulin biosimilars.”
“Insulin is extremely costly and often a barrier to sustained patient utilization,” Rariy tells Endocrine News. “And so having that insight and perspective into why the patient is getting that change, whether it happens at the provider level, or at the pharmacist it’s important to understand the reasoning behind it. The idea is that it’s more cost effective. It has safety data associated with it, and it’s a viable option for patients with diabetes. And so certainly I think an education campaign is important.”
Rariy goes on to says she’s witnessed insulin rationing in her own practice, even among patients with diabetes who have had a stroke, which was in part related to their poorly controlled diabetes. These patients are discharged from the hospital and given an insulin regimen, which can be an enormous cost that was never in their financial plans.
“I commend the FDA for advancing, and the Endocrine Society for providing that as a top priority to help to see what we can do to reduce the cost of insulin and approving this fast-tracked insulin biosimilar,” Rariy says “It’s still a relatively new process, so I haven’t had much experience with feedback from patients on how they are seeing the difference. But I think we just need more data, more research and making sure that we’re following the entire life cycle of the patient now that this is available.”