What can you tell me about biosimilars?

I know nothing. I need to know a lot and don’t have much time…

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I think of them as the “generic” version, at lower cost, and claim to be just as effective.

Here are examples for insulins.

"In fact, these follow-on insulins, listed below, have technically undergone the same transition as their reference products:

  • Eli Lilly’s Basaglar (insulin glargine follow-on to Sanofi’s Lantus)

  • Sanofi’s Admelog (insulin lispro follow-on to Eli Lilly’s Humalog)

  • Mylan’s Semglee (insulin glargine follow-on to Sanofi’s Lantus, which is under FDA review but was also filed under the 505(b)(2) pathway)"

More details here.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes

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MM1 gave a great answer on the biology front.

On the economics front, biosimilars (if approved) will allow competition for analog insulins. Hopefully lowering prices, or at least stopping prices from inflating at continuing crazy rates.

So far we don’t really have “generic biosimilars” for insulin. we just have different-brand-name almost-the-same-price biosimilars. So price rises not yet optimally kept in check.

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I think they believe that getting biosimilars listed under medicare will promote cheaper prices in the market overall. Does that seem right? Because the market follows medicare sometimes? And its easier to implement policy for medicare, than for the private marketplace.

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Biosimilars have proven safe and effective in other disease communities. However, they have yet to show strong price lowering potential. In insulin the market is different. So far insulin manufacturers have not taken the step of actively blocking biosimilars with litigation.

I support them entirely. Here is a bit of biosimilar knowledge.

One of the best selling RA medications Remiciade has two master batches. Now these are not Biosimilars. They are the official medicines. These two batches are owned by the company (Janssen) that owns the product. Batch 1 was established in the US, batch 2 in Europe.

Batch 1 and 2 are the root of all Remicaide made in the world. But over time these two batches evolve. They evolve in different ways. Slight differences, a little here and there but over time they become different. They are the same medication but they are now biosimilars of each other. It is no differnet that the entire biosimilar industry. They are the same, but different. Same properties, same outcome, different genetic product.

As one leading researcher said at ACR. Even the same brands are biosimilars of themselves. This does not mean they do not work. In fact they they do work. But they are similar not the same. it is the nature of making a living evolving product

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I was at the Type I Diabetes (T1D) Summit in 2019 and Jesse Bushman, JDRF’s Senior Director of Health Policy talked about generic insulin as a way to bring down the cost of insulin. IMG_20190309_092848|690x433
According to Bushman, generic Humalog is (literally) the same insulin, just costing less to “end rebate/kickback game” (see .jpg).

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All Super helpful information, everyone. Thanks so much.

Lol, @LWithrow. I remember that image from ages ago when you all tried to explain to me what a PBM was. I’ve looked for it since and had the hardest time finding it. Thanks for posting.

I read about that, RPhil. They say that the biosimilars are reducing price only around 15% (less than generics). The complaint might be that they aren’t getting placed on the list of covered medications by insurers. ???

Lol. I snapped that with my phone at the conference. I have since used the slide to explain the insanity and how insulin that used to cost $80/vial can now be $300/vial. The presenter, Bushman, likened the process like being on one of those old-schoolyard merry-go-rounds where your friend is going WAY too fast and you need to get off. You know the insanity will stop, but someone is going to get hurt.

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It’s pure greed. There is no reason for it to be this expensive.
In Canada it’s one tenth of the cost because the government negotiates the price.
They stick it to Americans because they can. Then they set up some shell game with cards and reduced prices to make it seem like they care.
If they cared they would lower the prices.
The two big guns, Lilly and novo are heavy into price fixing. They know we can’t do anything about it.

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The Mayo guys are working on it, too. I’ve heard them talk about it. I didn’t understand everything but I understood it was a mess.

At this moment PBM’s are not putting them on formularies thus keeping biosimilars out of the hands of patients. At present the biosimilar faces two terrible price issues. First, name brands filed complicated and expensive patent enforcement litigation. They settled this litigation by extracting high payments from biosimilar producers for a period of 2-6 years in exchange for dropping the litigation. Without agreeing to these terms the biosimilars would ave faced years upon years of litigation. It was extortion.

Second the PDM’s have demanded high rebates from the usual manufacturers in order to keep them on their formularies. This has the impact of making it so these manufacturers have not been able to ramp up production. Imagine selling a product 20% less expensive but having no buyers. All the tech to get it set up and yet no one to sell too.

This situation is slowly lifting as the patent litigation is nearing an end. We will see a large price drop int he near future. However, as this is occurring newer and better medications are coming to market that biosimilars cannot match for 5- 7 years. It ill be interesting.

The main issue in drug pricing is kickback schemes that PBM;s engage in.

As I said the insulin companies have not yet tired to litigate profitability, largely because they started making thier own biosimilars. Who can compete with the name brand biosimilar? No one.

And that is OK, and darn smart. Because the name brands are beating the PBM’s. Good for them

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There are more choices now than in the recent past for analogs. I have my choice between Humalog, Generic Humalog, and biosimilar rapid-acting. My insurance covers Humalog at $50/3 months. But if it didn’t Have insurance I could use a Lilly discount card and get it for $35 a month (which would actually work out to $70/3 months because I use 10 pens every 3 months so I would only fill twice in 3 months).

I would bet the “funny money” price to my insurance company is less than $20 per 1000 unit vial or less than $30 per 1500 units/3 pens. I.e. my insurance company is actually making a profit every time they pay for my insulin because I’m paying them more than their cost. But of course I have zero visibility into that.

In 1986 when I went to college and paid for insulin out of my own wages, Lilly Beef/Pork Regulat was about $8 per vial. With a little inflation the assumed “funny money” price doesn’t seem so bad. But it’s not the list price which is $300+.

All the insulin manufacturer discount card programs are limited duration and I would bet the instant congressional pressure shifts somewhere else the discounts completely disappear.

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Good response re: PBM’s. I don’t understand why health plans can’t do their own negotiating with Pharma (what are all their lawyers doing in the corner offices?). I liken it to shopping as a tourist in Tijuana. A vendor has items that he sells for $10. He sees a tourist coming, so now the asking price is $15 (knowing that the tourist wants the haggling experience and will offer $5). The process begins, back and forth, back and forth. Eventually they come to an agreement: $10.

What is especially unfortunate, that increased list price (by Pharma) remains the list/retail price - really hurting those without Rx coverage or high deductibles. And last estimate I saw for cost of mfr and dist of a vial is about $8.

It was 17 dollars per vial when I was diagnosed in 1987. Right when Humulin came out.

There are actual laws that prevent insurance companies and Medicare from negotiating drug prices in the US.
It’s crazy

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Yes, it is crazy. I am on Medicare plus a supplemental insurance policy. I use a pump and my insulin is paid for in its entirety with no cost for me. This last refill was filled as insulin aspart from Novo. Box was the same as Novolog but without reference to “Novolog.” There was no insert in the package. I got no warning from anyone about the change. I have no idea how much of a savings there was nor how much the “new” insulin aspart costs. I am sure that Novo Nordisk does not lose money on the change.