Medicines for type 1 and 2 diabetes including Lantus are costly. However, soon, individuals with diabetes will have another option which will be much cheaper in cost. The Food and Drug Administration (FDA) has now approved Semglee, a brand-new and long-acting insulin. Long-acting insulin is the one that takes a lot of time to start working. They may take 3-4 hours to get into the bloodstream.
This being a biosimilar insulin glargine and can be interchanged with different insulin glargine products. Other products include Lantus and Basaglar.
A pharmacist based in Florida, Joanna Lewis, PharmD, MBA, explained that in biologics, biosimilars are similar to generics, due to the inability of researchers to replicate its molecules.
The FDA‘s newly initiated pathway is used to approve the medicine. This pathway helps speed up the process of approving biosimilar drugs which can increase the market competition.
Acting associate director for therapeutics in the FDA, Dr. Patrick Archdeacon explained that such approvals underline the FDA’s longstanding dedication towards the support of a competing marketplace for insulin products.
Lowering Costs of Insulin
Semglee may not be much of a cheaper interchange as compared to Lantus and another insulin glargine.
However, the lead pharmacist and co-founder of Honeybee Health, Dr. Jessica Nouhavandi, PharmD, said that currently, there is hardly 3 long-lasting insulin in the market. Out of the three, two are made by one company and the other one is a marked ‘generic’.
She added that due to the very little competition in the field, there are minor chances for a new drug to be less expensive.
She explained that although advancing the FDA endorsement procedure may aid in reducing prices, she doesn’t believe that it would make a significant difference. Conventionally, prices have reduced only when an opportunity for several generics to join the industry, would exist.
The basis for the costs is due to the non-identical treatment between biosimilar drugs and generic drugs, according to Shashank Upadhye, an FDA lawyer.
Semglee will force the overall prices to fall as the payers will make it get market shares. There might be concessions by other sellers but it wouldn’t make much difference.
This can help as the FDA has approved new products, it led to more generic competition. However, the BLA doesn’t support automated replacement such as conventional tiny molecule pills. Hence, experts don’t expect the price concentration to be as critical, harsh, and rapid.
Rumors spread quickly regarding people going across the borders to Canada in an attempt to get the same drug that is available in the US at a higher cost.
Nouhavandi says that cost is a major factor in the lack of medications for patients. Although a cheaper drug is now in the market, not sufficient competition exists to lower prices.
Congress and the drug companies have taken measures to keep the prices lower. However, no central mandated cost control exists. This means that many patients would still not be able to get medicines.
The leading executive administrator of Biocon Biologics who made the medicine ‘Semglee’ had not announced whether they exist in the market for profit.
Christiane Hamacher, Ph.D., explained that their goal is to reach a $1 billion income objective by 2022, with 5 million subjects by the completion of 2022.
Nouhavandi said that the drug is already accessible in the UK. There is a ‘single-payer system’ in the UK which helps the government to cap costs. It makes sure that patients can afford life-saving drugs.