FDA Approves First Interchangeable Biosimilar Insulin Products for Treatment of Diabetes Today, the Food and Drug Administration approved the first interchangeable biosimilar product, Mylan's Semglee (insulin glargine-yfgn). Semglee (insulin glargine-yfgn) is both biosimilar to and interchangeable with Lantus (insulin glargine). As an interchangeable biosimilar product, Semglee (insulin glargine-yfgn) may be substituted for Lantus at the pharmacy-level without the intervention of the prescribing health care provider, subject to state pharmacy laws. Semglee is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. A product approved as an interchangeable biosimilar product means that a company sought approval as an interchangeable biosimilar, and FDA has concluded that it has met the standards for interchangeability. These standards include: - the interchangeable biosimilar product is biosimilar to the reference product,
- the interchangeable biosimilar product can be expected to produce the same clinical result as the reference product in any given patient, and
- the risk in terms of safety or diminished efficacy of alternating or switching between the interchangeable biosimilar biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.
FDA also released three fact sheets today for health care providers, including one about interchangable products. The agency also released an updated Consumer Update for patients and caregivers about interchangeable biological products. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product and the 30th biosimilar product approved in the U.S. 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 your 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. This approval furthers FDA's longstanding commitment to support a competitive marketplace for insulin products. The availability of interchangeable biosimilar insulin products can provide more treatment options to patients, potentially lowering treatment costs and enabling greater access for more patients. | 
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