The Food and Drug Administration 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.
What is the first approved biosimilar insulin product about?
It is Semglee (insulin glargine-yfgn), an interchangeable biosimilar with its reference product Lantus (insulin glargine). A long-acting insulin analog (may be substituted for it).
Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the US for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe options. As well as high quality and potentially profitable for the treatment of diabetes.
This is how the FDA said about the approval of the first biosimilar product for diabetes
“This is a momentous day for people who depend on insulin daily for the treatment of diabetes. Since biosimilar and interchangeable products have the potential to greatly reduce healthcare costs ”. Said Acting FDA Commissioner Janet Woodcock, MD.
Today’s approval of the first biosimilar product reinforces the FDA’s longstanding commitment to supporting a competitive market for biologics. And ultimately, it empowers patients by helping them increase access to safe, effective and high-quality drugs at potentially lower cost. “
What is a biosimilar?
Biologics include drugs to treat many serious diseases and chronic health conditions, including diabetes. A biosimilar is a biological product that is very similar and does not have clinically significant differences from a biological product already approved by the FDA (also called a reference product).
This means that you can expect the same safety and efficacy from the biosimilar that you would expect from the reference product.
An exchangeable biosimilar product can be substituted for the reference product without the intervention of the prescriber.
A low cost and reliable product
Substitution can occur at the pharmacy, a practice commonly called “pharmacy-level substitution.” Very similar to how generic drugs are substituted for brand-name drugs, subject to state pharmacy laws, which vary by state. Biosimilar and Interchangeable Products Have Potential to Lower Health Care Costs, similarly to how generic drugs have reduced costs.
“Access to affordable insulin is critical, and long-acting insulin products, such as insulin glargine, play an important role in treating type 1 and 2 diabetes mellitus,” said Peter Stein, MD, director of the Office of New FDA Drugs. Drug Evaluation and Research Center.
“The high FDA approval standards mean that healthcare professionals and patients can trust the safety and efficacy of an interchangeable biosimilar product, just as they would the reference product.”
RECOMMENDATIONS:
The dosage of Semglee (insulin glargine-yfgn), such as Lantus, it should be individualized according to the needs of the patient. Also, it should not be used during episodes of hypoglycemia (low blood sugar levels) or in patients with hypersensitivity to insulin glargine products.
Like Lantus, Semglee (insulin glargine-yfgn) it is not recommended for the treatment of diabetic ketoacidosis. Semglee (insulin glargine-yfgn) can cause serious side effects, including hypoglycemia (low blood sugar). As well as severe allergic reactions, hypokalemia (low potassium levels in the blood) and heart failure.
The most common side effects associated with insulin glargine products other than hypoglycemia include edema (fluid retention), lipodystrophy (injection site stinging).
Related Notes:
Is it safe for people with heart conditions to get the COVID vaccine?
What to do if someone is vaccinated and exposed to COVID?
Which COVID-19 vaccine is the most accepted worldwide?