FDA: Viatris’ insulin deemed ‘interchangeable’ biosimilar

pharmafile | July 30, 2021 | News story | Medical Communications  

Viatris has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – Sanofi’s once-daily insulin Lantus.

The Viatris biosimilar, Semglee, has been approved for over a year as a regular biosimilar to Latinus, which allows it to be used instead of Latinus but only if it is specifically prescribed for a patient.

The new interchangeable status now means that Semglee is considered to have no clinically meaningful difference to Lantus in safety, purity or potency, so can be substituted for the reference drug without any prescriber intervention – just like a regular generic drug can in many US states.

The approval of these insulin products comes at a much-needed time in the US as the cost of the drug continues to remain high despite patent expiration. There is currently debate among lawmakers, pointing the finger at companies such as Eli Lilly, Novo Nordisk, and Sanofi, accusing them of exploiting the public by maintaining high prices that can sometimes force diabetics to ration their use of the drugs.

However, biosimilars can provide patients with additional safe, high-quality, and potentially cost-effective options for treating diabetes. Biosimilars marketed in the US typically have list prices 15% to 35% lower than their reference products at launch.

Lantus is said to be the most administered basal insulin across the globe, raking in blockbuster sales for Sanofi. The first copycat Lantus – Eli Lilly/Boehringer Ingelheim’s Basaglar – was approved in the US in 2017, but that was approved as under a new drug application, not as a biosimilar, and so also needs to be specified by the prescriber.

Sanofi is reportedly defending its franchise by trying to switch patients to Toujeo, and longer-acting version of insulin glargine that made the company $300 million in the first quarter of this year.

Kat Jenkins

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