Komal Bavaskar, Mumbai university
Diabetes affects around 422 million people globally, with the majority residing in low- and middle-income countries, and diabetes is directly responsible for 1.6 million mortality per year. Diabetes has already been diagnosed in over 30 million people in India.
What is diabetes?
It is a metabolic disorder that results in elevated blood sugar levels. When you consume something, your body converts it into glucose (sugar), which enters your bloodstream and causes the pancreas to release the hormone insulin. Insulin promotes the entrance of glucose into your cells, where it is used to generate energy. When you have diabetes, your body either produces insufficient insulin or none at all. This causes a build-up of glucose in your circulation.
Diabetes is commonly classified into:
- Type 1 diabetes affects adolescents, teenagers, and young adults.
- Type 2 diabetes affects the elderly, as well as those in their forties and fifties.
- Gestational diabetes is a kind of diabetes that develops in pregnant women.
The FDA has authorized biological products for individuals who require insulin daily. The US Food and Drug Administration has approved the first interchangeable biosimilar insulin product for patients with Type 1 & Type 2 diabetes & to improve glycemic control.
What is a biosimilar product?
It is a biological product that is similar to a reference product or originator product. They are large complex molecules produced in a living organism.
Biosimilar product needs to meet these requirements:
- Biosimilar product has to be highly similar to a reference product i.e., they must look same, have the same primary sequence, the same type of secondary and tertiary structure helps in functions.
- There should be no clinically meaningful differences between the two products i.e., does it release & circulate in the body the same way? Is it getting to the same place at the same time to exert its clinical effect?
- The FDA approves a biosimilar after the applicant undergoes extensive evaluation and testing.
What is an interchangeable product?
A biosimilar product that meets extra standards specified in the Biologics Price Competition and Innovation Act is considered an interchangeable product.
Extra standards/requirements are:
- It must have the same clinical result in patients as a reference product.
- If a patient switches back & forth between an interchangeable product and a reference product, there must be no additional risk or loss of efficacy.
The first interchangeable biosimilar product which was approved by the FDA for the treatment of diabetes is Semglee (insulin glargine-yfgn). The approval of these insulin products may give patients more safety, high-quality, and possibly cost-effective diabetic treatment choices. This insulin was administered subcutaneously once a day. The FDA has approved Semglee (insulin glargine-yfgn) as a biosimilar and interchangeable with Lantus (insulin glargine) based on evidence that they meet the requirements such as highly similar, no clinically meaningful differences between Lantus (insulin glargine) and Semglee (insulin glargine-yfgn) & no risk in terms of safety, purity, and potency (effectiveness). It has demonstrated that Semglee (insulin glargine-yfgn) has the same clinical results with a reference product i.e, Lantus (insulin glargine). So, there will be no risk of loss of efficacy even if the patient decides to switch between these products.
Like Lantus, the dosage of Semglee should be based on individual needs and must be avoided for patients who are hypersensitive to insulin glargine and should not be administered during hypoglycemia.
Semglee (insulin glargine-yfgn) may produce some adverse effects like:
- Hypoglycemia (low blood sugar), hypokalemia (low potassium in the blood), and heart failure.
- Edema (fluid retention), lipodystrophy (pitting at the injection site), weight gain, and allergic responses such as injection site reactions, rash, redness, discomfort, and severe itching.
Also read: Taxallnomy- A taxonomic database that produces hierarchically complete taxonomic lineages
Reference:
- Commissioner, Office of the. ‘FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes’. FDA, 30 July 2021, https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes
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