Sigh of relief for people with diabetes as FDA approves first biosimilar insulin product

US – The U.S. Food and Drug Administration (FDA) has 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.

Approvals of these insulin products is set to provide diabetic patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.

Semglee, the approved insulin product, is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine), a long-acting insulin analog.

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.

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.

The 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.

About diabetes

According to a report study in Diabetologia, diabetes is a major global public health problem currently affecting 463 million individuals and projected to affect 700 million by 2045.

Estimates of prevalence suggest that the diabetes burden is increasing at a faster pace in low- to middle-income countries (LMICs) than in high-income countries (HICs).

In India, 77 million adults currently have diabetes and this number is expected to almost double to 134 million by 2045.

According to the report, people who live in cities and metropolitan areas in India are more likely to develop diabetes than ever before.

This is due, in part, to cities promoting a lifestyle that can increase a person’s body mass index (BMI). Having a higher BMI is a diabetes risk factor.

Rural areas in India are also experiencing a surge in type 2 diabetes cases, but more studies are necessary to fully understand how and why this is happening.

Overall, females have a higher risk of developing diabetes than males, but as both groups get older, this risk decreases.

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