Novo Nordisk Launches Authorized Generic Insulins, Gets FDA Approval for Fast-Acting Insulin in Pediatric Population

January 7, 2020

Novo Nordisk said 3 measures to make insulin more affordable are now available, and it also announced that the FDA expanded use of its fast-acting mealtime insulin to children as young as 2.

Novo Nordisk this month launched its authorized generics of NovoLog and NovoLog mix, available at a 50% list price discount compared with its brand-name versions. The announcement came as part of a package that Novo Nordisk said was aimed at making insulin more affordable.

The move comes 3 months before the March 2020 transition of insulin to regulation as biologics and biosimilars rather than drugs and generics; the company had announced the authorized generics last fall.

Also beginning this month: a previously-announced plan to allow patients to purchase up to 3 vials or 2 packs of pens for any combination of insulin for a flat fee of $99; the company has said it expects that amount of medication is sufficient for 1 month.

Lastly, the company also said it would offer a 1-time insulin supply option for no cost for when supply has run out and the patient might be in danger of skipping or rationing their doses. The supply would include 3 vials or 2 packs of pens for those with a prescription.

Last year, stories of insulin rationing by patients were heard at various hearings before Congressional committees discussing the issue of high drug costs in America. A report last June said insulin rationing is a problem globally, but worse in the United States.

The FDA is hoping that the transition to regulating insulin as a biologic in March will help increase competition.

The transition will take time, a company executive told The Center for Biosimilars® Monday, as it announced an expansion of its fast-acting mealtime insulin aspart to the pediatric population.

“I don’t see that this is going to be like a switch that goes off and there is an immediate transition,” said Todd Hobbs, MD, vice president and chief medical officer of Novo Nordisk in North America. Rather, he said, the change will probably encourage other developers to join the field and “lead to more competition down the line.”

Hobbs also said that for the first time, Novo Nordisk would have what he described as a “presence” at the 38th Annual J.P. Morgan Healthcare Conference, with presentations likely geared towards their future pipeline.

On Monday, the FDA expanded the company's fast-acting mealtime insulin aspart, marketed as Fiasp, for use in children as young as two. The product was first approved by the FDA in 2017 for adults for use by intravenous injection in a medical setting or by subcutaneous multiple daily injections. Last fall the product was also approved for use in insulin infusion pumps.

The dosing options for children are the same as adults, and Hobbs said it is priced at the same as NovoLog.


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