It was way back in March of 2015 when the first biosimilar was approved. There was much consternation over the impact that biosimilars would have on the ‘land of plenty’ world of brand name drugs. As we all know, those concerns never realized as the biggest impediment to triggering a shift to the ‘copycat drugs’ was the lack of interchangeability.
The interchangeability ceiling was finally broken last week with the approval of the first interchangeable biosimilar insulin product, Semglee (insulin glargine-yfgn) from Mylan, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee is both biosimilar to and interchangeable with its reference product, Lantus (insulin glargine), a long-acting insulin analog.
It is ironic that the first interchangeable biosimilar is for a non-specialty therapy when much of the original concern over biosimilars related to specialty biologics. As we know, the biologics that have been approved and are commercially available are for therapies not generally dispensed by specialty pharmacies. The remainder are NOT available commercially as they have have been sidelined due to massive legal challenges usually related to patent protections.
Patients have long awaited relief from brand prices and have been disappointed. The approval of Semglee finally delivers measurable relief. The GoodRx price for Semglee with a coupon is only $104 compared to the reference product, Lantus, at more than $400.
Side notes
First, now that we have proof of interchangeability will the FDA be more inclined to grant that designation to other biosimilars dispensed by specialty pharmacies. Probably. However, having an interchangeable designation won’t remove the legal roadblocks can keep FDA approved biosimilars off the commercial market for years.
Second, Walmart announced that it will start selling its own private brand of analog insulin at prices up to a 75% discount to competing products. The private-brand insulin will cost $73 per vial and $86 per FlexPen, prices that are 58% to 75% lower than other insulin products. Details as to source for the ‘private brand’ were not released.
FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
July 28, 2021 — Today, 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 mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved 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.
“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. “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.”
Biological products include medications for treating many serious illnesses and chronic health conditions, including diabetes. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). This means you can expect the same safety and effectiveness from the biosimilar as you would the reference product.
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. Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. 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.
More than 34 million people in the U.S. today have been diagnosed with diabetes, which is a chronic (long-lasting) health condition that affects how the body stores and uses sugars and other nutrients for energy. Most food is broken down into sugar (also called glucose) and released into the bloodstream. When blood sugar levels increase, it signals the pancreas to release insulin, which acts like a key to allow blood sugar to enter the body’s cells for use as energy. With diabetes, the body doesn’t make enough insulin to keep sugar levels regulated in the normal range.
“Access to affordable insulin is critical and long-acting insulin products, like insulin glargine, play an important role in the treatment of Types 1 and 2 diabetes mellitus,” said Peter Stein, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “The FDA’s high standards for approval mean health care professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product.”
All biological products are approved only after they meet the FDA’s rigorous approval standards. The approval of Semglee (insulin glargine-yfgn) as biosimilar to, and interchangeable with Lantus (insulin glargine), is based on evidence that showed the products are highly similar and that there are no clinically meaningful differences between Semglee (insulin glargine-yfgn) and Lantus (insulin glargine) in terms of safety, purity and potency (safety and effectiveness). It also showed that Semglee (insulin glargine-yfgn) can be expected to produce the same clinical result as Lantus (insulin glargine) in any given patient and that the risks in terms of safety or diminished efficacy of switching between Semglee (insulin glargine-yfgn) and Lantus (insulin glargine) is not greater than the risk of using Lantus (insulin glargine) without such switching.
Semglee (insulin glargine-yfgn), offered in 10 mL vials and 3 mL prefilled pens, is administered subcutaneously once daily. Dosing of Semglee (insulin glargine-yfgn), like Lantus, should be individualized based on the patient’s needs and should not be used during episodes of hypoglycemia (low blood sugar) or in patients with hypersensitivity to insulin glargine products. Also, like Lantus, Semglee (insulin glargine-yfgn) is not recommended for treating diabetic ketoacidosis. Semglee (insulin glargine-yfgn) may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions, hypokalemia (low potassium in blood) and heart failure. The most common side effects associated with insulin glargine products other than hypoglycemia include edema (fluid retention), lipodystrophy (pitting at the injection site), weight gain and allergic reactions, such as injection site reactions, rash, redness, pain and severe itching.
The FDA released new materials for health care providers to enhance understanding about biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.
The FDA granted approval of Semglee (insulin glargine-yfgn) to Mylan Pharmaceuticals Inc.
