Will Humira Go Generic?

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JackG

JackG

Joined
Apr 3, 2015
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In the last 6 months to a year I have read in several places that Humira is due to go generic this fall. I have also heard they are tweaking the drug to avoid this.

The drug is currently $4000 a month in Illinois; I would be interested in what it costs round the world. But the point is, I have reached my full retirement age, but I CAN'T RETIRE because Medicare and the supplements won't fully pay this blatant extortion by Abbvie.

Anybody have news about this??
 
Biologics don't necessarily "go generic". Due to their formulation other companies can create biosimilars. Remicade already has one on the market in the U.S. and I think 2 in Europe.

The formulation for Humira has been tweaked but in anew effort to bring down the pH so the injections will be less painful.

With biosimilar they have to go through a process with the FDA to ensure that the formulation is safe and will have the same effect.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological 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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Source
 
JackG said:
In the last 6 months to a year I have read in several places that Humira is due to go generic this fall. I have also heard they are tweaking the drug to avoid this.

The drug is currently $4000 a month in Illinois; I would be interested in what it costs round the world. But the point is, I have reached my full retirement age, but I CAN'T RETIRE because Medicare and the supplements won't fully pay this blatant extortion by Abbvie.

Anybody have news about this??
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With Medicare what would be your responsibility? I'm lucky that between insurance and Humira Complete I only pay $5 (I believe, haven't been billed yet) but am horrified that someone not as lucky would have to pay such ridiculous prices out of pocket.
 
My insurance coverage while working is the same as yours, Dan.

I've been researching for two years trying to retire and Medicare itself only covers half, and even then you have to come up with about $8000 in January and February just to blow through their various levels into catastrophic coverage.

I had a broker and a friend looking at all the Medi-gap supplements and they will only cover another quarter. That would leave me owing $1000 a month just for Humira. Given that Abbie has upped their price $400 in the three years I've been on it suggests it's not a fixed amount I can plan for.

Humira is being prescribed now for 11 different conditions, and its growing as one of the bigger money makers in pharacuetical history. Of course at $4000 a month for two shots I suppose it would be. Next time we have a hurricane I have some plywood to sell you at $1000 a sheet.
 
The issue is when you have federal insurance such as Medicare or Medicaid you no longer are eligible for things like humira complete. This is fine if you qualify for Medicaid since it covers all of it but Medicare simply does not .
Have you looked at the catastrophic out of pocket max. ?
I know once you hit that the price you pay is either free or greatly reduced .
Not a good system at all .
 
Medicaid applies to people on disability, which I am not.

I'm not sure of the figures because its been 6 months since I last actively pursued it, but the approximately $8000 out of pocket figure is the maximum I'd have to hit to go into catastrophic coverage. But even then, and after supplemental coverage, I would still owe the $1000 a month.

BTW Abbvie itself is quick to say that they have an aid package for people who can't pay. But I would have to retire first before I could even apply. And doesn't the word "apply" suggest the possibility of a refusal? Last year I approached 10 other sources of aid, suggested by my doctor and our local Senior Advantage. 6 of them said "all their funds were committed" and the others needed me to retire first and then submit my tax forms.

Would you retire with that uncertainty? How do you get from the day you retire until your next tax forms with Humira at $4000 a month?
 
JackG said:
Medicaid applies to people on disability, which I am not.

I'm not sure of the figures because its been 6 months since I last actively pursued it, but the approximately $8000 out of pocket figure is the maximum I'd have to hit to go into catastrophic coverage. But even then, and after supplemental coverage, I would still owe the $1000 a month.

BTW Abbvie itself is quick to say that they have an aid package for people who can't pay. But I would have to retire first before I could even apply. And doesn't the word "apply" suggest the possibility of a refusal? Last year I approached 10 other sources of aid, suggested by my doctor and our local Senior Advantage. 6 of them said "all their funds were committed" and the others needed me to retire first and then submit my tax forms.

Would you retire with that uncertainty? How do you get from the day you retire until your next tax forms with Humira at $4000 a month?
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I am so sorry .
 
Ron, while I appreciate your empathy, it's really not a "sorry" thing. It's an exploitation by unregulated big business. If I as a boomer am having trouble retiring, how are younger Crohn's people going to do it?

Humira is great, but nothing legitimately costs $4000 for two shots, especially when hundreds of thousands of people are taking it for 11 different conditions. According to the Chicago Tribune, local Abbvie is making multiple billions of dollars a year, and they are trying to defeat efforts at going generic. A handful of companies are close on their heels with biosimilars, but ultra rich Abbvie may crush them.

Fans of unregulated big business should remember Enron and the banking crisis of 2008. Success can raise all boats, but unchecked it also can destroy all boats.
 
Did you have the option of remicade or humira? When my Mom required a biologic for her RA the rheumatologist recommended remicade because it falls under the medical side whereas humira falls under the prescription side. So, with Medicare and whatever supplement she has she doesn't payou but a couple hundred each year for remicade. Humira would've been more expensive but I don't remember her saying it would be $1000 a month more like per year but I'd have to ask her again.

There's always the option of switching to remicade but it would stick to burn through a med that's working.
 
Clash I know more than a few retired folks on humira and Medicare
The price per month of $1000 or more is correct unfortunately
Not sure in the remicade side of Medicare
But might be worth looking into
 
I just talked with my Mom. With remicade, Medicare picks up 80% of it and the supplement picks up the other 20% so she doesn't actually pay anything.

She was just put on a med because her bone density went from normal to horrible in 5 years. The med was Forteo and after medicare she was still going to have an 800 a month out of pocket expense. Luckily, Lilly's patient assistance, Lilycares, is picking up the out of pocket expense.

That's a shame about humira and the cost.
 
I've known about Remicade being infused in the hospital and covered by Medicare, as opposed to Humira being a self injected shot and only partially covered from the first. I started on Humira because of it's low incidence of rejection.

The problem now is, if I switch and my body rejects Remicade, then I've lost Humira and Remicade. That's a problem when there's only 3 or 4 meds of this kind. My GI also thinks there is some evidence that the next med and the next med will be progressively less effective, meaning I may need other meds on top of whatever we end up with, Cimzia, for example, if that works.

I am being conservative to protect my options; obviously I'm not a silent one. Sorry.
 
my little penguin said:
http://www.raps.org/Regulatory-Focu...-Unanimously-Backs-Amgen’s-Humira-Biosimilar/


The costs are only a little cheaper - not by much
If remicade biosimilars are any indicators
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It's so ridiculous. How many billions of dollars have these companies made? How much money is enough money for people to have? Why do they need 10 trillion freakin dollars?

Why are the generics not pushing the prices down more? All they have to do to replicate this drug is to HPLC it to find out the chemicals and amounts, and it is so easy to inject a 5 year old can do it.

These generics should be pushing the price down way more. I don't understand why remicade doesn't have 5 other generics.
 
Poppysocks said:
It's so ridiculous. How many billions of dollars have these companies made? How much money is enough money for people to have? Why do they need 10 trillion freakin dollars?

Why are the generics not pushing the prices down more? All they have to do to replicate this drug is to HPLC it to find out the chemicals and amounts, and it is so easy to inject a 5 year old can do it.

These generics should be pushing the price down way more. I don't understand why remicade doesn't have 5 other generics.
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Agree
 
Poppysocks said:
Why are the generics not pushing the prices down more? All they have to do to replicate this drug is to HPLC it to find out the chemicals and amounts, and it is so easy to inject a 5 year old can do it.

These generics should be pushing the price down way more. I don't understand why remicade doesn't have 5 other generics.
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This is incorrect. Biologics such as Remicade and Humira are antibodies which are large and complex proteins that are grown in either living cells or cell-free protein expression systems. They are not simple molecules that can be easily sorted out on an HPLC and synthesized in a flask.

To give some idea of the relative size and complexities we are talking about here let's consider two different IBD drugs: azathioprine and Remicade. Aza is a typical small-molecule drug with a molecular weight of 277. Remicade is a typical protein biologic drug with a molecular weight of approximately 149,000. Remicade is therefore about 538 times the size of azathioprine. Since it's also an antibody Humira is close to the same size as Remicade.

In part this difference in degrees of size and complexity is why the FDA invented the whole concept of "biosimilar" - because it's easy to prove that your generic copy of azathioprine is chemically identical to the original. But for a molecule over 500 times larger it becomes impossible to prove that every one of the thousands of carbon, nitrogen and, hydrogen atoms that comprise your candidate generic copy of Remicade molecule is put together in exactly the same chemical arrangement as the original. If FDA had not come up with the biosimilar category there would never be any generic versions of biologic drugs at all. It would be an impossible task.

Thus, instead of proving that your generic is identical, drug makers only have to prove it is "similar." But even proving similar is still a huge and expensive undertaking. The FDA tends to be a very skeptical and risk-averse organization. They require a lot of data to be convinced of anything, especially with serious diseases like Crohn's and potentially risky drugs like injectables. Add that to the huge technical hurdles of making the drug in the first place and you get some idea why the biosimilars are only a little cheaper than the originals - because even though it's a copy, it's still a very long and difficult process to make, test, and validate that the large, complex, generic has the same or very similar structure, function, and biological effects as the original. If it were cheap and easy to make and cheap and easy to get through the FDA there would be dozens of generic Remicades already.
 
I am confused. How can drugs like Humira and Remicade be called antibodies and at the same time there is a concern about building up antibodies against this drugs? Maybe I read it wrong. I am not trying to cause problems.
 
No, Ron you've got it right. The drugs Humira and Remcade are antibodies and so are the antibodies your body sometimes produces that decreases the effectiveness of those drugs.

First let's consider the drug Remicade. It is an antibody that was originally produced by injecting a mouse with human TNF. So it's a mouse antibody that attacks a human protein. If you injected that mouse protein into a human the human's immune system would correctly perceive it as a foreign mouse protein and attack it by making it's own antibodies, not against TNF but against the mouse antibody.

So for the mouse drug to be able to block the TNF it has to evade the human immune system. They do that through recombinant DNA technology. Mouse antibodies and human antibodies are very similar but with some distinct differences. It is these differences that trigger the human immune response against the drug. So through the gene cutting and splicing technology they take out all the parts of the antibody molecule that are characteristic of mouse antibodies and replace them with the corresponding human segments. They thus "humanize" mouse protein into a human protein.

This humanized anti-TNF is then a useful drug that can block parts of the human immune system and thus decrease the inflammation of Crohn's and other inflammatory diseases. But unfortunately there are still a few minor or subtle differences that, eventually over time, will elicit an immune response from humans receiving the drug. These are the antibodies that cause the Remicade to lose its effectiveness after a while. The story is similar for Humira except that it didn't start out as a mouse protein.

So the short answer is Remicade is an antibody against TNF and the your immune response consists of antibodies against Remicade - an antibody against an antibody. Confusing I know, but that's Crohn's for you. Nothing is ever easy and simple with this disease.
 
An article that I recently read in the business press that focused on the contribution of Humira to Abbvie's bottom line announced that the US patent protection for Humira is scheduled to expire December 31, 2016. However, the author of the article speculated that since the European patent has another three years to run, it was felt to be highly unlikely that a competitor would attempt to enter the market since a large segment of users are European. I suppose that that means that a generic is unlikely to be on the market any time soon.
Market price in this area is around $2000 per pen.
 
I am so glad for my insurance. After reading this thread I decided to go to my insurance company's website and look up what the cost is for Humira. My last refill total cost was $4,085.59. With Humira Complete I am only paying $5.00 per refill. So I am very thankful for that. I am also thankful that when I retire my employer will pay for a supplemental insurance package. I think if I was in your position, Jack, that I would consider switching to Remicade because of the out of pocket cost of the Humira. Hate to say that because Humira has been a good med for me, and apparently for you as well.
 
Doug, I would like to change over to Remicade, and my GI has even offered to do it for retirement purposes. Another Crohn's person says I'd probably feel better on it. But my GI has also put the fear of God in me about diminishing alternatives.

If I leave Humira and then my body rejects Remicade, I've built antibodies against both. Then I only have a couple options: Cimzia and....whatever. The safer thing is to use Humira as long as it protects me.

Here's another idea: my GI and his nurse say that if I retire, they can almost guarantee they can get aid from Humira's maker Abbvie. They say it casually, but I'm the one retiring knowing I need $4000 a month for ONE med. I've already applied while I'm still working, and of course I don't qualify. But if I retire and apply....

Doesn't the word "apply" suggest there may be a refusal? And by the way, you have to re-apply every year, not knowing whether your application will be accepted. "They take care of retirees," the nurse says.
I've spent 40 years working for big companies and I know how reliable those words are.

Anybody have any thoughts on switching meds?
 
My son has been through remicade and humira. He is now on stelara (in phase 3 trials at higher doses it's shown good results for CD). His other option was entyvio. There's still Cimzia but I doubt wed try it since he doesn't seem to fully respond to tnf biologics.

There's several drugs in phase 3 studies right now that show promise for CD.

I can understand your concern. I hated having to leave remicade as I had read several articles and studies that show it was the most effective and although it didn't completely quell my son's inflammation it got him in to state where he was at least asymptomatic.

Our problem is my son needs biologics that treat both his CD and Spondyloarthropathy. That is, at this point, the tnf blockers and stelara.

There's a thread on here that is an ongoing list of what's out there, close to approval and showing promise in trials if you want to take a look.

We had the same concern with my son's stelara prescription because his dose is that of the phase 3 trial and not what is now approved (for psoriasis) so the payment assistance program rejected it because of the high dosage. At one point, the specialty pharmacy said our out of pocket for the first 4 shots would be 68,000! But the GI spoke with them and we went back and forth and the out of pocket expense ended up being 40 dollars. Still, appealing the payment assistance program which would being it to 5 dollars a month. But if it stays at 40 bucks I'm cool with that!
 
The problem is once your on a federally funded program of any kind ( Medicare Medicaid etc..)
Then you don't qualify at all for the Abbvie sponsored assistance - this is true for all drug company's for any drug
Please look at the fine print
 
Little Pidgeon, my understanding as to the reason for the disallowance of users of Medicare and Medicade (and other government programs) from having access to pharmaceutical company's discount programs grew out of US government "back room" negotiations with Big Pharma. Government wanted their support for Medicare part D expansion (and later Obamacare legislation), and Pharma wanted assurances that the government would not use their expanded purchasing power to drive prices down. Recall how Big Pharma had killed "Hillarycare" in the 90's with a multi-million dollar ad campaign. So, the deal was struck and all US government programs pay full list price with no discounts allowed.
With drug prices now exploding upward and pharmaceutical profits following suit, it may be time for a further negotiation?
 
At those prices overseas travel might be justified for a discount. Is it available in India or other countries less expensively?
 
I just saw this article that talks exactly about OP's question.

  1. Amgen is set to get an approval on their Humira biosimilar ABP-501 on September 25.
  2. Coherus CHS-1420 is another Humira biosimilar pushing through the approval process.
  3. AbbVie is gearing up to fight tooth-and-nail against any biosimilars to Humira as the drug is their bread-and-butter. They expect to be able to drag on the process until about 2022. Of course, the PTO or Courts may muck up their plans by any major rulings against them.

We may get some good signals on how heated the Humira biosimilar wars will be in the next few months, especially after the expected approval of Amgen's offering this month.
 
Thank you, xeridea. I called, they signed me up for Humira Complete and a Nurse Ambassador will be calling within a day. I had not heard of this service either from my GI and his nurse, nor in my research.

I will keep the board posted in my journey to find that lost city called retirement.
 
JackG said:
Thank you, xeridea. I called, they signed me up for Humira Complete and a Nurse Ambassador will be calling within a day. I had not heard of this service either from my GI and his nurse, nor in my research.

I will keep the board posted in my journey to find that lost city called retirement.
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They were very helpful when I had a misfire. They're really on top of things and I get a discount as well.
 

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