[kkreamer]

I totally agree with you regarding drug prices overall, but insulin is different in this respect. A vial of Humalog cost $35 in 2001. The exact same size vial of the exact same insulin -- no refreshed patent, no reformulations, no improvements, no change whatsoever -- cost $270 in 2017. If the price would have only followed inflation, it would have been $48.50 in 2017.

[michael_j_ward]

Are you 100% certain that it's the exact same vial? This [1] article claims that Humalog's patents expired in 2013 and 2014.

If you're right, do you know why no generic producers of the drug were able to enter the market by 2017?

[1] https://www.pbs.org/newshour/health/insulin-market-shakeup-p...

[kkreamer]

Yes, I am 100% certain.

Insulins are biologic medicines, so once patents expire you might get biosimilar drugs which also require FDA approval, not generics as with other drugs. Admelog is the biosimilar for Humalog, approved by the FDA in early 2018.

As I understand it, Sanofi (Admelog's manufacturer) sets the price to be only slightly below that of Humalog.

Eli Lilly, Novo Nordisk, and Sanofi manufacture substantially all of the insulin, and they more or less follow each other price-wise. There's not the competition you would expect that would drive down prices.

EDIT: they compete by offering varying discounts to particular insurance companies to only cover their insulin at the exclusion of the other company's insulins. This often leads to a letter to patients near the end of the year telling them that the insurance company has decided that their treatment plan has now changed, decisions of their doctor be damned. (Yes, you can appeal and what-not, but it's still fundamentally the insurance company's decision, not your doctor.) This, of course, also screws anyone without insurance who is expected to pay list price.

[michael_j_ward]

Gracias for the information. I had to look up biologic medicine to understand what the difference is with other drugs like say acetaminophen. This article from forbes laid it out [1].

TLDR:

1) Biologic / large molecule drugs (insulin) are much harder to produce than small molecule drugs like acetaminophen.

2) The FDA thus requires a lengthly, costly approval process to make generic large-molecule drugs. And since often these drugs are not atom-by-atom the same like small molecule drugs, they are referred to as "bio-similar"

3) Additionally- though least clear from the article, while the patent on a large molecule drug does expire after 20 years in the same way as small-molecule drugs, it appears that the larger-molecule gives a wider area to patents that can be applied to it. The article hints at, but does not make explicit, a mechanism for "evergreening" as I tried to clarify elsewhere in these comments.

Anyways, thought I'd write it up the TLDR because this background info would have been useful to know prior to engaging in this comment section.

Gracias again

[1] https://www.forbes.com/sites/theapothecary/2019/03/08/biolog...