What is “Authorized Generic” Insulin?

Aug 10, 2021 by David Wood

What is “Authorized Generic” Insulin?
There is a new term floating around in the world of insulin production: authorized generic. If you read our article on biosimilars, then you already know there is no such thing as a generic when it comes to biologic pharmaceuticals like insulin. 

So that begs the question, what on earth is an authorized generic insulin?

The answer is definitely not what you would expect.

There are currently three insulins available in the United States that have been deemed authorized generics by the FDA, according to HealthLine

The first is insulin lispro, which is made by Eli Lilly as a lower priced version of Humalog. The problem? Insulin lispro IS Humalog. The two products are identical aside from the label and name.

The other two authorized generics are made by Novo Nordisk. Insulin aspart is the authorized generic of their top-seller, NovoLog. And insulin aspart mix is the generic of their 70/30 mix. Both products are identical to the insulins they were made to be the generic of.

So what is an authorized generic insulin? The exact same thing as the brand name but with a different label, different name, and (slightly) lower price tag.

This answer only creates a lot more questions. For one, if it is possible to make the same insulin using the same method and sell it for a lower price, why not just lower the price of the brand name insulin? And, more to the point, why would companies make a low-priced version of their top selling insulin?

The answer: because congress is demanding insulin prices be reduced. By responding to those demands by offering affordable insulin options, the big insulin companies can appease congress and avoid them taking more extreme measures such as passing price cap bills.

But, in truth, authorized generics are not an answer to anything. They are nothing more than a PR stunt.

The distribution and supply of these affordable insulins are controlled 100% by the companies that make them. And those companies have a vested interest in not letting their generics out-compete their identical, more expensive products. 

Analysis of prescription availability found that only 8% of Humalog prescriptions filled in 2019 were filled with generic insulin lispro and that the generic was not widely available or advertised in pharmacies across the country.

Meanwhile, the price of brand name insulins continues to rise and profits for the Big Three insulin makers continue to break records.

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