FDA Greenlights First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes



The U.S. Food and Drug Administration on July 28 announced the approval of the first interchangeable biosimilar insulin product aimed at enhancing glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is biosimilar that can substitute for Lantus (insulin glargine), a long-acting insulin analog. Semglee (insulin-glargine-yfgn) is the first interchangeable biosimilar product approved in the United States for treating diabetes. Approving these insulin products can offer patients additional safe, premium-quality and cost-effective means for treating diabetes.


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


Biological products include drugs for combating several serious diseases and chronic health conditions, including diabetes. A biosimilar is a biologic that shares similarities to a biologic. Biosimilar tends to possess no clinical differences from a biologic approved by the FDA (also known as the reference product). This implies you can expect similar level of safety and effectiveness from the biosimilar as you would in the reference product.


An interchangeable biosimilar product may be exchanged with the reference product without the prescriber intervening. The exchange may take place at the pharmacy, a practice popularly known as “pharmacy-level substitution” – similar to how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which are different across states. Biosimilar and interchangeable biosimilar products have the likelihood to lower health care costs, much like how generic meds have lowered costs. Biosimilars marketed in the U.S. usually have launched with initial costs 15% to 35% less than comparative list prices of the reference products.


Over 34 million individuals in the U.S. today have been diagnosed with diabetes, which is a chronic (long-lasting) health ailment that impairs how the body stores and utilizes sugars and other nutrients for energy. Most food is broken down into sugar (also known as glucose) and sent into the bloodstream. When blood sugar levels go up, it signals the pancreas to release insulin, which serves as a key to let body sugar enter the body’s cells for use as energy. With diabetes, the body doesn’t produce 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,” explained 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 tough approval standards. The approval of Semglee (insulin glargine-yfgn) as biosimilar to, and substitutable with Lantus (insulin glargine), is based on proof that showed the products are largely similar and that there are no clinically noteworthy differences between Lantus (insulin glargine) and Semglee (insulin-glargine-yfgn) with respect to purity, potency and safety (effectiveness and safety). It also confirmed that Semglee (insulin glargine-yfgn) can be expected to offer the same clinical result as Lantus (insulin glargine) in any given patient and that the risks in terms of safety or diminished efficacy of interchanging between Semglee and Lantus is less than the risk of using Lantus without interchanging.


Semglee, marketed in 10 mL vials and 3 mL prefilled pens, is given subcutaneously once daily. Dosing of Semglee, like Lantus, should be individualized according to the patient’s needs and should not be utilized during episodes of hypoglycemia (low blood sugar) or in patients with hypersensitivity to insulin glargine products. Also, similar to Lantus, Semglee is not recommended for treatment of diabetic ketoacidosis. Semglee may lead to adverse side effects, including hypoglycemia, hypokalemia (low potassium in blood), chronic allergic reactions, and heart failure. The most popular side effects linked with insulin glargine products aside hypoglycemia are weight gain, lipodystrophy (pitting at the injection site), edema (fluid rejection), and allergic reactions, such as rash, pain, severe itching, redness and injection site reactions.


The FDA granted approval of Semglee to Mylan Pharmaceuticals Inc.