On Wednesday, the U.S. Food and Drug Administration (FDA) announced the approval of the first interchangeable biosimilar insulin product, called Semglee, which improves blood sugar control in adults and pediatric patients with type 1 diabetes and adults with type 2 diabetes.
Semglee (insulin glargine-yfgn) is biosimilar to and interchangeable with its reference product Lantus (insulin glargine), which is a long-acting insulin analog. It is the first interchangeable biosimilar product approved by the FDA for the treatment of diabetes.
Approval of these biosimilar insulin products could offer patients safe, high-quality, and potentially cost-effective options for treating diabetes, according to the FDA.
FDA’s Acting Commissioner Dr. Janet Woodcock said, “This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs.”
“Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” she added.
The FDA’s approval of an “interchangeable” biosimilar could save people with diabetes and health plans millions each year, according to the Associated Press.
Semglee pens, developed by Viatris Inc., cost about $150 to $190 for a month’s supply, without insurance. On the other hand, Lantus costs you around $340 to $520 for a month’s supply.
Viatris is seeking FDA approval of another biosimilar of long-lasting insulin, according to Medicine Net.
Health data company IQVIA has suggested that savings from the use of biosimilars will exceed $100 billion in the United States from 2020 to 2024.
Compared to Europe, the sales of biosimilars in the United States are much lower, probably due to factors such as red tape, lengthy patents, and opposition from brand-name drug makers, according to the Associated Press.
Sean McGowan, Senior Director of Biosimilars, AmerisourceBergen, told the Associated Press, “Only 20 of 29 FDA-approved biosimilars — for cancer and immune disorders like rheumatoid arthritis — are currently available in the United States.”
“These products are highly similar, but much more affordable,” he added. AmerisourceBergen is a leading drug wholesaler that provides a crucial link between pharmaceutical companies and healthcare providers.
