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FDA approval means that pharmacists can swap biosimilar Semglee, an insulin product, for brand-name Lantus, although state-level pharmacy rules may apply.
FDA’s approval last week of the first biosimlar and interchangeable insulin for type 2 diabetes could save the U.S. healthcare system hundreds of millions of dollars, an analyst says.
Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product, Sanofi’s Lantus (insulin glargine). Being interchangeable means that Semglee doesn’t need to be explicitly prescribed and can be substituted for Lantus by a pharmacist who is filling the prescription. However, state-level pharmacy rules and regulations govern some aspects of interchangeability.
The FDA has approved 29 biosimilars but Semglee is the first that was approved as being interchangeable with its brand-name reference product.
The FDA approved Semglee last year and it has been on the market since but the interchangeable designation could increase its use and might lead to price competition between Semglee and Lantus.
“The U.S. healthcare system could potentially be able to save hundreds of millions from 2020 to 2030 from the prescribing of Semglee or ‘insulin glargine’, eroding the market share of Lantus as with interchangeability status pharmacists would be able to dispense the less expensive Semglee in comparison to Lantus,” Akash Patel, pharma analyst for GlobalData, told Managed Healthcare Executive®.
Biocon Biologics developed Semglee and Biocon’s distribution partner is Viatris, a new company formed by a merger between Mylan and Upjohn.
Viatris said in a press release last week that the interchangeable version of Semglee will be introduced before the end of this year and that it will transition its current product to the interchangeable product over the next few months. The Viatris press release says company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus.
The launch of biosimilar interchangeable insulin products leads to an increasingly competitive insulin market and is often welcomed by physicians and patients due to the likely reduction in list prices, Patel said.
However, the effect of the interchangeability status of Semglee can be challenging to predict “as lower prices often mean larger rebates for pharmacy benefit managers and healthcare payers, as cost savings are often not observed by the patient,” Patel said.
Semglee current U.S. average wholesale acquisition cost (WAC) is $65 per vial while the WAC price for Lantus and Basaglar, another competitor insulin glargine, are $283.56 (Lantus 10ml) and $97 (an average of Basaglar 3ml and 5x3ml pens), Patel noted.