Hacker News new | ask | show | jobs
by projektfu 1224 days ago
A lot of formerly protected insulins, e.g. insulin glargine, are off patent now. The remaining moat for generics consists of FDA approval, delivery system patents, and manufacturing process patents/trade secrets. For a generic insulin to get FDA approval it needs bioequivalence which is a lot like running the original safety and effect studies over again, while dealing with spurious injunctions and the like from the company with the name brand. If you get to the finish line as a private company, you're going to price it where you can get some of the market but not get into a price war with the name brand.

California, on the other hand, is paying a lot of money to Novo Nordisk et al, and would benefit from reaching a low average price. They can afford to go through the approval process with all the important insulin analogs. And they won't go bankrupt in court before it pays off.
2 comments
basch 1224 days ago
>insulin glargine, are off patent now.

In the U.S.A. is expected to expire on 2027-07-05.

How did something invented in 1994/2000, get patented in 2009? https://patents.google.com/patent/US8048854B2/en%3C/

link
projektfu 1224 days ago
That's a different molecule. It's been animated.
link
basch 1224 days ago
Do they still make/prescribe the non animated one? Did it just disappear off the market?
link
projektfu 1223 days ago
I think that's just a Wikipedia red herring. I'm not sure the amidated glargine has been marketed.
link
RcouF1uZ4gsC 1224 days ago
>. For a generic insulin to get FDA approval it needs bioequivalence which is a lot like running the original safety and effect studies over again

That is incorrect. A bioequivalence study is much simpler and cheaper than the original safety and efficacy studies.

You do not need to prove that safety and efficacy of the drug, only that you are delivering the equivalent of the originally studied drug at the same doses.

https://en.wikipedia.org/wiki/Bioequivalence

link
peyton 1224 days ago
No, the submission packages for anything chronically administered (like insulin follow-on) are way more comprehensive.
link
projektfu 1224 days ago
Thank you. Insulin, being a biological, can't prove equivalence through just equivalent pharmacokinetics and contents.
link