USFDA okays Biocon insulin Semglee as first interchangeable biosimilar drug

The US drug regulator has approved Biocon’s Semglee, the first interchangeable biosimilar insulin product, to treat diabetes patients. This means that Semglee can be substituted for its reference drug – Sanofi’s Lantus – by a pharmacist in the US without any intervention of the prescriber. Lantus is a long-acting insulin glargine.

The move will empower patients by “helping to increase access to safe, effective and high-quality medications at potentially lower cost”, the US Food and Drug Administration (USFDA) said in a statement. Semglee will be manufactured by Biocon Biologics, a subsidiary of the Bengaluru-headquartered firm, and marketed by its partner Viatris Inc (earlier Mylan Pharmaceuticals Inc) in the US.

Speaking to Business Standard, Shreehas Tambe, deputy CEO of Biocon Biologics, said that the product might soon be available in India too (as an interchangeable option for Lantus), provided the regulatory pathway was cleared.

Analysts expect additional revenues of 8 to 15 per cent for Biocon, with no competition in sight.

Biocon Biologics Chairperson Kiran Mazumdar-Shaw said: “We are extremely proud to be the first to obtain approval for an interchangeable biosimilar product in the US. It is a milestone achievement for both Biocon Biologics and our partner Viatris. This will allow pharmacy-level substitution and thereby provide convenient and affordable access to Semglee.”

The USFDA called it a momentous day for people who rely daily on insulin for treatment of diabetes. “Biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Acting FDA Commissioner Janet Woodcock.

Typically, biosimilars are marketed in the US at 15-35 per cent lower price than the innovator biological products. Insulin, however, is a complex segment, with high-entry barriers and only a few global players operating in this space, reducing the pricing pressure.
 

The insulin market in the US is highly concentrated. Only three companies — Novo Nordisk, Sanofi, and Eli Lilly — supply insulin to patients in the US. These three companies, commonly called the ‘Big Three’, control over 90 per cent of the global insulin market. The remaining share of the global insulin market is split among about seven manufacturers.

Based on the reported sales in 2020, insulin glargine (Lantus and Basaglar) had sales of $4.2 billion globally, of which $1.9 billon was in the US. Some analysts said Biocon could have a 6 to15 per cent market share in the insulin glargine segment in the US by FY23. 

The interchangeable Semglee product will be introduced before the end of the year, Biocon said. Biocon is also eligible to have exclusivity for 12 months before the USFDA can approve another biosimilar interchangeable to Lantus.

“Commercial preparations for the launch are underway. Over the next few months, Viatris will transition the current product to the 351(k) interchangeable product,” it added.

Basically, if a patient switches to Semglee from Lantus, there is no difference in the expected outcome on blood sugar level controls. The USFDA assesses the purity, potency, and the safety of a product before allowing interchangeability.