Recently, the U.S. Food and Drug Administration has given approval to a new treatment option for patients of both type 1 and type 2 diabetes. The biosimilar substitute may be especially helpful for those diabetic patients who are long-term users of insulin injectables such as Lantus.
The alternative, which will be marketed under the name of Semglee is a biosimilar insulin glargine. This means that this long-acting insulin can be used along with other glargine including the aforementioned Lantus, Basalgar, and Toujeo.
Joanna Lewis, who is a pharmacist in Florida, explains “Biosimilars are like generics for biologics. Because their molecules cannot really be replicated, they are biosimilar because they are made from living organisms and not small-molecule generics.”
The approval of Semglee not only provides a new option to patients of type 1 and type 2 diabetes but also paves the way for the usage of a new regulatory pathway by the FDA. The pathway allows the health agency to review and approve other biosimilars for diabetic patients.
Quicker reviews and approvals are important to ensure all diabetic patients are able to afford insulin for managing their health as it will increase the number of options and encourage market competition, thereby bringing down the price of insulin injectables.
The acting associate director for therapeutics in the FDA’s Division of Diabetes, Lipid Disorders, and Obesity, Office of New Drugs, Dr. Patrick Archdeacon, stated in a recent press release that the use of the new regulatory pathway accentuates the health agency’s committed action towards bringing down the price of insulin injectables and products in order to make them more accessible and economical.
However, pharmacists have stated that the approval of the new biosimilar may not make a significant difference. Currently, there are a total of three biosimilars present in the market. One of them is comparatively lower in price while the rest are manufactured by the same company.
The efforts by the FDA can make a big difference but only after a long period of time when there are enough products to create competition. In the case of insulin injectables and other products used by type 1 and type 2 diabetes patients, this may not happen soon and the newly approved Semglee may only make a slight difference in price.
The high price of insulin products in the US is the reason for hundreds of deaths in diabetic patients. Many patients cannot simply afford using injectables which may lead them to use less than their prescribed dosage or not use it at all. Reports on the issue have also shown that a number of people travel all the way to other countries including China to buy insulin products at a cheaper rate.
However, the prices just seem to go up with every passing year. The primary reason for this is the healthcare system in the US itself which gives the power to drug manufacturers to maintain a higher price. In comparison, the healthcare system in the UK is very different. Under the single-payer system, the government of UK is able to cut down prices of certain drugs and make them more accessible to the majority.
Many have argued that drug manufacturers have too much power in the US, which explains how insulin products for type 1 and type 2 diabetes as well as many other treatments are unaffordable for the vast majority.