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Seriously off topic question about pharma and insulin
Not sure where else I could ask my question and get answered by other knowledgeable scientific people. (taking suggestions)
I heard a “diabetic organization” (not the ADA) is working with a “drug manufacturer” to make and distribute “biosimiliar insulin” and plan to release this insulin(s) on the market next year. Besides the obvious this is of concern because of the nature of being insulin. Wouldn’t this company have to jump through the same peer reviews and testing/clinicals? How is the FDA involve? Couldn’t we ask to see the results of the clinicals. Wouldn’t they need some sort of 5-10K since this has to be injected? Are my concerned founded?
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19 Replies
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I think if you need to see their definition of “biosimilar” and assess if it really IS that innovative.You can’t try and equate Cosmetic Regulatory to the manufacture of Legend Drugs. The testing and documentation is significantly more involved. Unless the system fails completely, testing will be mandated. -
I don’t think a company could get away with introducing a new drug without doing any published test. Perhaps they meant they are just going to make a generic insulin? They’d still have to do testing though.
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@Perry My guess is that they are simply applying creative marketing to use “biosimilar” for products created using yeast and recombinant technology. While creative, it is hardly new as this has been a standard process for at least 20 years now.
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Thank you everybody for the answers!
There are only 3 companies that are responsible for all the mass majority of the world’s supply of insulin. California and a “diabetic organization” are both saying they will sponsor their own insulin. I was familiar with yeast and recombinant technology being used.
When news like this hits the diabetic world it runs like wild fire without cautious review of what is being said…everybody will say its a cure!!! This group makes it sound like they were able to pull off new insulin in a few years with this pharma company much like the covid vaccine (yes another fascinating topic). I am being skeptical.Biosimiliar insulin is “A biosimilar product is a biologic product that is approved based on demonstrating that it is highly similar to an FDA‐approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.”
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Insulin is a very old drug May 17, 1921, Frederick Banting and Charles Best, under the direction of J. J. R. Macleod, isolated what would later be known as insulin in a lab at the University of Toronto. Why is insulin so expensive in the US, because they price their medications according to what the market will bear, not what it cost to produce.
FDA has a regulatory process for bio-similar. drugs, https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes#:~:text=Today%2C%20the%20U.S.%20Food%20and,with%20Type%202%20diabetes%20mellitus.
It is probably legit since large pharma/biotech like Genentech, Eli Lili, and others have been lobbying heavily against having any competition cut into their profits.
I worked for the pharmaceutical industry as a sales representative, and later sold equipment to the life science industry. -
Interesting story about Insulin. The original inventors intended for Insulin to be made widely available at cost + modest profit since they wanted all who needed Insulin to be able to purchase it inexpensively and it was readily available. They licensed the patent for $1.00. Little did they know that 100 years later Insulin would be sold for price gouging-level profit margins.
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Registration for biosimilars has become a lot easier and cheaper recent years, similar to generic drugs wherein most of the data (except the ‘similarity’) don’t have to be provided.Every country has its own way to set prices… Here in Switzerland prices are usually higher (not always, though) than in neighboring countries and human insulin costs about $ 50-60 for 5 pens with each 300 IU, a 10 ml ampule with 1’000 IU about $ 25, and modified insulins or combinations cost between $ 60 and 100 for 5 pens. What’s the US prices, if I may ask? -
@Pharma
Thanks for responding….
The price for a vial of insulin ranges from $50 to over $1,000, and a pack of pens ranges from $45 to over $600. The prices may vary ( not much) if you have insurance too. I use to have insurance where I was getting $35 for 5 pens. Don’t work there anymore…..
The top 3 insulin companies are now offering $35 vouchers for insulin. When the fever dies down this will go away again. They do this with other drugs from time to time…. -
@Stanley Why is the price range so wide? Even the lowest price is a bit high. Do elderly have to pay for insulin?
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Great question…
Yes, elderly, noninsured and people who are insured (depending on their plan). There is alot that goes into actual pricing.Plenty of articles of the tangled web of insulin pricing/gouging and the pharmaceutical lobbyists that try to keep the prices high. Have you noticed the high percentage of Pharma execs transitioning into Gov’t positions?
The 3 main insulin manufacturers of insulin have cornered 90% of the global market so they can price it anyway they want with little competition. This is why people are looking at biosimiliar insulin to save the day. I just question if all the clearances will be done or is this rush to market for a product people cant live without…
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@Syl
Yes I know insulin is a Canadian discovery. Often tell people if it wasn’t purified it wouldn’t be as useful so make sure you include all 4 scientist! I do believe they discover was when noticed in dogs. -
@Stanley, I did not know about that fact.
I understand your concerns, there is always risks associated with trying a new drug especially insulin. It would be best if there was a price cap (which unfortunately did not pass in the senate). I would look if the of state California has rebates programs to help you. Gavin Newsom is upset with insulin pricing and is making it a priority. He also wants to manufacture it in the state. https//www.pharmaceutical-technology.com/news/california-insulin/
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@Stanley, I contacted my friend who works at Stanford hospital in the GI department, she sent an insulin saving guide which recommends biosimilars, she also mentioned goodrx and mark cuban pharmacy. Do you want me to forward you the guide?
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@Syl
Thank you so much! Perhaps we can continue this conversation outside of the group if you don’t mind. I would definitely like the guide. I am involve in the Diabetic community. I am familiar with Ca and Gavin Newsom. I can’t say that I really trust his motives or the people that are working on him on this. He has faced recall twice. :#I believe you can send me an DM to my inbox and we can further the conversation. thanks!
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I personally don’t concern about efficacy. There will be 2 more hitting the US market soon. Make sure you monitor yourself.
But this
An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state.
If I were the prescriber, I would like to be notified before interchange.From outsider POV, you should have passed universal health care.
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@Pattsi Thanks for the information. Would the insulin by Civica be one of the insulins that will be hitting the US market soon?
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I see so many article about low-carb & Ketogenic diet which reverse diabetics. I am not diabetic. and also some patience are now insulin free. Just saying.
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You’re right to be cautious about new biosimilar drugs, especially with something as essential as insulin. Just like with HGH—which has strict testing and approval processes due to its direct effects on the body—insulin biosimilars go through extensive testing. The FDA requires that biosimilars show they’re safe, effective, and practically identical to the original. Any new insulin product has to prove itself through rigorous trials.
For injected drugs like insulin (and HGH), the manufacturer also needs specific approvals for safe delivery. The FDA monitors this process closely, and yes, they’ll make parts of the clinical data publicly available. So your concerns are understandable, but these safety nets are in place to make sure any new biosimilar works as well as the original.
If you’re interested in learning more about the safety measures for HGH, this article has useful information: HGH Replacement Therapy Side Effects.
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