FDA Allows Generic Swap Of Insulin

The FDA (Food and drug administration) has taken a positive step by allowing a generic swap for the brand name Insulin. This move by the FDA will mean that pharmacists can sell a cheaper brand with the same generic composition when a customer asks for insulin.

FDA Allows Generic Swap Of Insulin

There is already permission for generic pills and pharmacists can swap prescribed pills with similar generic names.

But this is the first time that the FDA has allowed a swap of an interchangeable similar to an injected drug. Insulin is actually a biological medicine that is manufactured inside living cells. This means that manufacturers can make cheaper versions of insulin and pharmacists can substitute them, though doctors will need to prescribe a biosimilar for pharmacists to follow.

There are other biologic drugs besides insulin. They are growth or thyroid hormones. Biologic drugs are used to treat a variety of ailments such as anemia, cancer, inflammatory bowel disease, psoriasis, and rheumatoid arthritis.  

This move will save both diabetics and health care institutions millions of dollars a year in the United States. The Health data company IQVIA has projected that the use of biosimilars like insulin will be $100 billion in a few year periods from 2020 to 2024.

Lantus is fast-acting insulin widely used in the United States. This can be interchanged with Semglee from Viatris Inc. A month’s supply of Semglee injectors costs from $150 to $190 as compared to $340 to $520 for similar Lantus kits.

Amerisource Bergen is a major drug wholesaler that has a biosimilar wing. Sean McGowan, head of the biosimilar division of Amerisource Bergen says that biosimilars are almost the same thing but much more affordable.            

The FDA has approved 29 biosimilars, mostly in cancer and immune disorders but only 20 biosimilars are available and being sold in the United States today.  

Insulin is actually a hormone that is naturally produced by beta cells in the pancreas within the human body and is produced as and when different foods are consumed so that carbohydrates and sugars are converted to a form that can be used by the body for energy. The body cannot survive without insulin and death from diabetes was very high until Frederick Banting and Charles Best discovered insulin in the year 1900.  

Insulin that is administered externally is a synthetic version made in a laboratory and is similar to the natural insulin secreted in the body. There are several types of insulin that are classified as long-acting, short-acting, rapid-acting, ultralong acting, and intermediate-acting insulins.

Insulins are injected under the skin subcutaneously and can be injector by disposable injector pens, insulin pumps, and a conventional syringe using an insulin vial.

Biosimilar insulins have actually been approved due to the patents of existing insulin brands expiring. There are presently 3 biosimilars of insulin available in the market. The biosimilars are Basaglar which is a biosimilar of Lantus (Insulin glargine), Admelog which is a biosimilar of Humalog (Insulin Lispro), and Truapi which is a biosimilar of Novo rapid (Insulin Aspart). Biosimilar insulins are also known as follow-on insulins.

While there are benefits of using biosimilar drugs such as insulin, their benefits may be negated if there is no reference biological insulin available. Hence, diabetics who are using insulin regularly must ensure there is a reference biologic available as there is a risk of the original reference biomedical going out of the market if its patent is expiring.

Health care officials recommend that patients get biosimilar insulin prescribed by their diabetologist or endocrinologist before opting for biosimilar insulin just for the cost-benefit. 

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