In this article, we will understand the meaning of biosimilar insulin, the role of the FDA in releasing a biosimilar, and the Semglee and Lantus variations of insulin.
Before we try to understand biosimilar insulin, let us know what insulin and biosimilar stand for.
Location of secretion: Insulin is a hormone secreted by the islets of Langerhans in the pancreas.
The function of Insulin: Insulin plays an essential role in regulating and maintaining normal blood glucose levels by promoting the utilization of glucose by the cells.
What happens during insulin deficiency or insulin resistance?
During insulin deficiency, the body experiences a constant rise in blood glucose levels, and in insulin resistance, the cells of the body are unable to respond to insulin so, the glucose builds up in the blood leading to prolonged high blood glucose levels.
Both of these conditions lead to the disease which is widely known as diabetes where the body is unable to regulate blood glucose naturally.
To treat diabetes, insulin is administered externally for maintaining blood sugar levels.
Insulin is being produced outside the human body with the help of genetics and biotechnology, the kind of insulin being produced in the market is widely known as “humulin” since it closely resembles the insulin produced by the human body.
This insulin is being marketed and sold over the years under a patent.
What are patents?
Patents are legal documents or licenses which give the complete authority or grant of producing, manufacturing, and selling a product exclusively to a particular brand.
What are biosimilars?
These patents can expire and the license of producing this product can be given to manufacturing the “biosimilars” which may not completely represent the original product but are similar to the original in biological development.
Biosimilar insulin is the type of insulin that is almost an identical copy of the original insulin that was predominantly developed and manufactured and whose patent is to be expired.
Approval of biosimilars by the FDA
The FDA is the Food and Drug Administration authority under the US govt. assures-
of the drugs released before they are released into the market.
The FDA approves the release of biosimilars or interchangeable products and continues to do so, provided that it follows the stringent guidelines which ensure the quality and safety of the developed products.
The FDA does so to encourage innovations in the field of medical science and at the same time, it keeps a check on whether the product is in line with the original product and to what degree.
Semglee and Lantus:
- Lantus is referred to as the long-acting man-made insulin for the management of Diabetes mellitus in adults and children.
- Lantus is also commonly sold as an “insulin-glargine injection”
- Lantus cannot be used in treating diabetic ketoacidosis which is a fatal condition if untreated.
- It should not be taken if the patient is having an episode of hypoglycemia or low blood sugar.
- It cannot be used for treating type 2 diabetes in children of any age.
On the other hand,
- Semglee is an affordable substitute for the original insulin.
- Semglee was the first to earn the designation of “interchangeable” insulin which means it can be substituted for Lantus in a pharmacy without needing a doctor’s prescription.
- Semglee is manufactured by the companies Biocon and Viatris which is less popularly known as compared to the big name manufacturing brands like Eli Lily.
- Semglee has been approved to be administered to patients with either type 1 or type 2 and can also be given to treat children from ages 6 to 15 years for treating diabetes.
- It is a long-acting form of insulin that can be commonly seen in the market as “insulin-glargine” or “insulin-glargine-yfgn” with different product names.
Given the approval by the FDA and the increase in demand for insulin with the rising number of diabetic patients, the release of biosimilars or generic medicines which closely resemble the original product may continue to develop to enable access to more people with various degrees of affordability.
Consult a medical practitioner to know the type of insulin best for you with consideration of factors such as how long you have had diabetes, lifestyle habits, and affordability.