FDA Approves First Interchangeable, Biosimilar Insulin for Treatment of Diabetes

Data show no clinically meaningful difference between insulin glargine-yfgn and insulin glargine in matters of safety, purity and potency.

The US Food and Drug Administration (FDA) has approved the interchangeable biosimilar product insulin glargine-yfgn (Semglee) for the treatment of diabetes.

The agent is a long-acting human insulin analog with an indication to improve glycemic control in both adult and pediatric patients with type 1 diabetes (T1D) and type 2 diabetes (T2D).

The approval for the first interchangeable biosimilar product in the United States to treat diabetes was granted to Mylan Pharmaceuticals, Inc.

Approval

As an interchangeable biosimilar product, the insulin-glargine-yfgn can be substituted for insulin glargine at the pharmacy-level without the intervention of the prescribing health care provider.

The standards for approval included the agent must be biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any patient.

Further, the risk in terms of safety or diminished efficacy of switching between the interchangeable product and the reference product can not be greater than the risk of the reference product without alternating between the 2 agents.

The agent met FDA approval for interchangeability based on evidence showing the products were highly similar, with no clinically meaningful difference between insulin glargine-yfgn and the insulin glargine in matters of safety, purity and potency.

In addition, the insulin glargine-yfgn is expected to produce the same clinical result as insulin glargine in any patient, with no risk in safety and efficacy from switching between the 2 agents compared to the use of the reference product.

Agent

The insulin glargine-yfgn is administered subcutaneously once daily. It is offered in 10 mL vials or 3 mL prefilled pens.

Its approval noted the dosing on insulin glargine-yfgn should be individualized based on patient need and should not be used during an episode of hypoglycemia, or patients with hypersensitivity to insulin glargine.

There were serious side effects observed, including hypoglycemia, severe allergic reactions, hypokalemia, and heart failure.

The most common side effects of insulin glargine products included edema, lipodystrophy, weight gain, and allergic reactions including injection site reactions.

Reaction

Janet Woodcock, MD, acting FDA commissioner, noted in a statement that the interchangeable biosimilar product may greatly reduce healthcare costs in patients who rely on insulin daily for diabetes management.

“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,” Woodcock said.

Peter Stein, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, agreed with the importance of access to affordable insulin and noted the FDA’s standards of approval for biosimilar products.

“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,” Stein said.