The U.S. Food and Drug Administration (FDA) has approved its third insulin biosimilar (biopharmaceutical generic) product. The pharmaceutical industry hopes that with an increase in biosimilars, the insulin supply shortage caused by declining revenue can be addressed, and the stagnation in the insulin market can also be overcome.
On the 14th, the FDA approved a product license for Merilog, an insulin biosimilar from the French pharmaceutical company Sanofi. Merilog is the first product to replicate NovoLog, an insulin product from Denmark's Novo Nordisk.
Insulin is a hormone secreted by the pancreas that regulates blood sugar levels in the body. If insulin is not secreted properly or does not function normally, it can lead to diabetes, which results in excessively high blood sugar levels. Diabetes patients must inject insulin to artificially regulate their blood sugar.
The pharmaceutical and bio industries, along with regulatory authorities, expect that the recent approval of Merilog will somewhat alleviate the stagnation in the insulin market caused by the popularity of glucagon-like peptide (GLP)-1 class diabetes treatments.
GLP-1 class diabetes treatments like Wegovy from Novo Nordisk and Mounjaro from Eli Lilly have created a shortage due to their known effectiveness in treating obesity. Although both companies accounted for a majority of global insulin production, they have recently reduced insulin production and concentrated on GLP-1 production amidst the current demand for obesity medications.
The reduction or cessation of insulin production by global pharmaceutical companies is due to declining revenue. Since the U.S. Congress has demanded price cuts for insulin, prices have fallen more than 70% since 2023. Pharmaceutical companies are left with no choice but to focus on producing GLP-1, which is relatively more profitable.
Novo Nordisk has announced that it will stop producing its insulin product, Levemir, after the end of 2024. Eli Lilly is also reducing its production volume of its insulin product, Humalog. There was a warning last March about a sudden drop in Humalog production that could lead to supply issues due to depleted inventory.
A shortage of insulin has also occurred recently in South Korea. In 2023, some diabetes patients experienced difficulties obtaining insulin at pharmacies. A representative from the pharmaceutical industry noted, "I understand that there are still cases in some pharmacies where insulin is not available on time," adding that "It is necessary for the insulin biosimilar product lineup in Korea to increase further."
Although two types of insulin biosimilars previously approved by the FDA have arrived in South Korea, alternative prescriptions are challenging. If diabetes patients use a product other than the insulin they were previously administered, they must go through procedures to reassess blood sugar reduction effects and adjust dosages.