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An FDA First: Semglee Is Approved As An Interchangeable Biosimilar


FDA approval means that pharmacists can swap biosimilar Semglee, an insulin product, for brand-name Lantus, although state-level pharmacy rules may apply.

In what may usher in a new era of competition on price among insulin products, FDA has approved the first interchangeable biosimilar insulin product.

Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product, Sanofi’s Lantus (insulin glargine), according to the FDA approval yesterday. Being interchangeble means that Semglee doesn’t need to be explicitly prescribed and can be substituted for Lantus by a pharmacist who is filling the prescription.\

The FDA has approved 29 biosimilars but Semglee is the first that wasapproved as being interchangeable with its brand-name reference product.

The FDA approved Semglee last year and it has been on the market since but interchangeable designation is likely to increase its use and is intended to stir up vigorous price competition between Semglee and Lantus.

Theinterchangeabilityapproval was announced yesterday in a press release by the FDA. Biocon Biologics developed Semglee and Biocon’s distribution partner is Viatris, a company that is the result of a merger between Mylan and Upjohn.

“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., in the release.

The approval “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 added.

Biosimilars in the U.S. typically have launched with initial list prices that are 15% to 35% lower than the list prices of the reference products, FDA said.

“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.S., 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.”

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber, FDA explained. The substitution may occur at the pharmacy — “pharmacy-level substitution”—much like generic small-molecule drugs are now substituted for brand-name drugs, although there is state-to-state variability because state-level pharmacy laws apply to interchangeability. In most states, patients will need to be told they are getting an interchangeable biosimilar and pharmacists will not be allowed to make the switch if the prescribing physician have expressly indicated they are prescribing the reference product (in this case, Lantus).

The approval of Semglee as an interchangeable biosimilar to Lantus is based on evidence that showed the products are highly similar and that there are no clinically meaningful differences between them.

Research has shown that Semgleecan be expected to produce the same clinical result as Lantus in any given patient and that the risks in terms of safety or diminished efficacy of switching between Semglee and Lantus (insulin glargine) is not greater than the risk of using Lantus without such switching, the FDA said.B

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.

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