[ProjectInsulin]

Hi Rayiner, you are spot on with your analysis. My name is Eric, and my non-profit, Project Insulin, is tackling this problem head-on as well. We are developing a biosimilar insulin and will distribute it directly to patients at cost. The drug development process is still expensive but much cheaper because of the Biologics Act that was passed in 2020. When going through the FDA approval process, biosimilar insulin makers don't have to do phase 2 trials, and their phase 1 & phase 3 are focused on interchangeability with the reference product rather than proving that insulin is a way to lower high blood sugars.

Another obstacle, as you pointed out, is that there are few manufacturers who produce synthetic insulins. From what I've learned in my discussions with manufacturers is that many are transitioning their facilities to a focus on mRNA drug manufacturing. Therefore there is a limited set of manufacturers who don't make insulin but have the equipment/facilities for it (in the U.S.).

[coldpie]

Hi Eric! I'm a T1D and so super interested in this space. Can you comment on whether it is the case that "modern" insulins (Lantus and Humalog/Novolog, in my case) are both covered by current patents, and also considerably better for patient outcomes (faster acting, more predictable -> lower A1c) than non-covered insulins? That is my understanding for why cheap, high quality insulins are not available, but I'd love to be informed if it is not the case! Thank you for your work in this area!

[MAGZine]

(not OP). some quick googling reveals lantus is no longer covered by patents. patents in the usa last 20y, and they filed the main patent for that drug in 1994.

it looks like they tried to patent some pen injection mechanism as a way to artificially extend the patent, but the patents were tossed out. I think that's a similar approach to how the Epi-pen people have maintained control, except their pursuit was successful (epinephrine isn't exactly a new chemical, nor is the process for manufacture).

still--manufacture of these drugs is long and expensive process, esp with fda approval. new entrants want to recoup their cost. the public is a great institution to develop generics because it can happily do so without a profit motive.

[pkaye]

I think Humalog/Novalog patents expired a while back. These companies will probably focus on other newer drugs for profitability like Semaglutide which is useful for dealing T2D and obesity.

Another thing that needs to be investigated is how much the PBMs (Pharmacy Benefits Managers) prpfit from the spread of drug pricing. Are they marking these drugs up a lot? Do they need to be tightly regulated?

[kridsdale1]

Jokes on them. I can buy raw semaglutide powder two steps off a Google search at 10% of retail.

[ProjectInsulin]

Hi as some of the others have already mentioned Lantus is off patent. My organization is focused on insulin glargine but there are generic versions of insulin lispro and aspart. Which is the generic/biosimilar version of humalog/novolog. We decided to stick with glargine first and transition to the other versions as we progress.

[hertzdog]

Hi Eric, my name is Francesco. In the last three years we industrialized a novel method for producing biosimilar insulin (in Italy). We are an international team and I really would like to contact you. Can you write to the email you find on my profile?

[ProjectInsulin]

Hi Francesco looks like you found me! I will respond to your email shortly :)

[atlasunshrugged]

Hey Eric, somewhat tangential question -- why is it that seemingly all precursor manufacturing is done in China or India? Is it just a low-cost game or are regulations making it too expensive to do in the U.S. or something else?

[ProjectInsulin]

This is a great question. Simply it is a lot cheaper to make drugs in China + India. The APIs cost less, and the workforce is cheaper. With regards to regulations I don't want to generalize but it has been well documented that it is hard for the FDA to regulate drugs being produced outside of the United States.

[6nf]

Why is insulin not expensive in other countries?

[ProjectInsulin]

While I don't know the answer to this in-depth I can share some bullet points and of course it depends on what country you are talking about. On top of that it is important to note that there are insulin shortages in various countries.

- one payer healthcare systems - non-convoluted distribution systems - depending where cheaper workforce/cheaper to make the insulin - less stringent regulatory processes - stronger lobbying groups in the US

[6nf]

There are no shortages in Australia, only the Eli Lily brand is low in stock but all other brands are available.

I've never heard of anyone unable to find insulin in Australia.

https://apps.tga.gov.au/Prod/msi/Search/Tradename//53488

[rayiner]

Very cool. This is much needed.