Lilly may seek biologics designation for Retatrutide

oldrunnerguy said:

Based on what I've gathered, should Retatrutide receive this classification, Lilly might gain free rein over how they set prices. I'm hoping that isn't the case. Time to start building a stash, perhaps! https://investor.lilly.com/news-rel...agonist-retatrutide-successful-two-additional.
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The only way stockpiling matters is if you believe today's suppliers will honor US patent rules and halt manufacturing. For those in this community who have no intention of ever purchasing from Lilly, that makes no difference.
 
My stockpiling remark was meant as a joke, though I'm genuinely curious how Lilly plans to go after the gray market for Reta. That market must already be enormous, no?
 
They have the freedom to set any price they want. But they're in for a rude awakening once they realize US insurers won't pay for it, and customers in Europe and the UK—who typically cover private prescriptions themselves (unless they go gray)—don't have endless money to spend.
 
Zuul said:

They have the freedom to set any price they want. But they're in for a rude awakening once they realize US insurers won't pay for it, and customers in Europe and the UK—who typically cover private prescriptions themselves (unless they go gray)—don't have endless money to spend.
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And it's worth adding that what people pay abroad is never close to the figures seen in the US 👎👎👎
 
If that happens, wouldn't it affect earlier drugs produced in a comparable way that never received biologic status? I hope the FDA stands by its earlier classification.
 
oldrunnerguy said:

Based on what I've gathered, should Retatrutide receive this classification, Lilly might gain free rein over how they set prices. I'm hoping that isn't the case. Time to start building a stash, perhaps! https://investor.lilly.com/news-rel...agonist-retatrutide-successful-two-additional.
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I'm curious how they'd even manage that at this point, since it seems like they haven't pulled it off yet. From what I can tell, they're already busy with other tactics—restricting access to bac water, syringes, and similar supplies. It makes me wonder what other sinister workarounds they'll dream up to shut out people buying on the grey market.
 
If Lilly manages to secure a biologic designation for Retatrutide and then slaps a sky-high price on it as the latest miracle of miracles, my guess is their following move (or payoff) would involve eliminating compounding, which is a big supplier of Tirz. After that, they'd be free to set Tirz's price however they like as a cheaper fallback for the unwashed masses who can't swing Reta, reclaiming that segment from the compounders.

Then again, I'm just a Liberal Arts grad, not a finance person. 😆
 
Zuul said:

They have the freedom to set any price they want. But they're in for a rude awakening once they realize US insurers won't pay for it, and customers in Europe and the UK—who typically cover private prescriptions themselves (unless they go gray)—don't have endless money to spend.
Click to expand...

Across much of the EU, using GLP-1 drugs for weight loss remains largely stigmatized. On top of that, the cost is prohibitive because insurers refuse to pay unless a person already has diabetes.

Many physicians from older generations won't prescribe these medications to patients who are merely overweight, absent any comorbid condition. If no comorbidity exists, the topic never even comes up.

My sister-in-law, age 47, has a BMI nearing 40. Her doctor prescribed sartans and statins and never brought up GLP-1s. He did warn her that she must shed weight immediately or she will head directly into type 2 diabetes.

The twisted irony is that should she develop diabetes, suffer a heart attack, or get cancer, her health insurance (Belgium) would then cover everything.

Lilly had better run some awareness campaigns in the EU!
 
The odds of them securing biologic status are basically nil regardless. Right now they're in active litigation against the FDA, because the FDA's rule says a chain needs 40+ aminos to count as a biologic, and Reta has just 39 (that's only one of the issues).

I'd really like to know what legal argument Eli Lilly would present to get the FDA to revisit its classification criteria, or to win some kind of exception — that would be a massive disruption to the whole framework, and you'd have everyone and their brother trying to reclassify or demand the same treatment... But cash has a loud voice, so who knows 🤷

When you get right down to it, the folks who call me "honey" and "dear" couldn't care less about biologic versus not, and neither will I lol.
 
deleted.user.27 said:

No need to worry everyone, cocaine remains available and works well to curb hunger. It's a fantastic fat burner, plus it costs less abroad too.🤣🤣
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Pfft, coke is such a Gen 1 skunk—just you wait until you get a taste of Methjaro! Shed pounds AND your pearly whites!
 
BBA1969 said:

Zuul said:

They have the freedom to set any price they want. But they're in for a rude awakening once they realize US insurers won't pay for it, and customers in Europe and the UK—who typically cover private prescriptions themselves (unless they go gray)—don't have endless money to spend.
Click to expand...

Across much of the EU, using GLP-1 drugs for weight loss remains largely stigmatized. On top of that, the cost is prohibitive because insurers refuse to pay unless a person already has diabetes.

Many physicians from older generations won't prescribe these medications to patients who are merely overweight, absent any comorbid condition. If no comorbidity exists, the topic never even comes up.

My sister-in-law, age 47, has a BMI nearing 40. Her doctor prescribed sartans and statins and never brought up GLP-1s. He did warn her that she must shed weight immediately or she will head directly into type 2 diabetes.

The twisted irony is that should she develop diabetes, suffer a heart attack, or get cancer, her health insurance (Belgium) would then cover everything.

Lilly had better run some awareness campaigns in the EU!
Click to expand...
Every day I'm reminded that not involving my doctor is a blessing. It's as if their only role in my life is to poke holes in whatever I do for my health.
 
oldrunnerguy said:

Based on what I've gathered, should Retatrutide receive this classification, Lilly might gain free rein over how they set prices. I'm hoping that isn't the case. Time to start building a stash, perhaps! https://investor.lilly.com/news-rel...agonist-retatrutide-successful-two-additional.
Click to expand...
If the designation were changed, that wouldn't affect what they charge, it would affect the length of their patient rights (12 years versus 7, if I remember right, though I'm not certain). On top of that, even after patient rights lapsed, compounding pharmacies aren't able to make biologics (in theory they could, but not one has ever been licensed for it), so competition in the generic market would be thinner.

unclebuff702 said:

The odds of them securing biologic status are basically nil regardless. Right now they're in active litigation against the FDA, because the FDA's rule says a chain needs 40+ aminos to count as a biologic, and Reta has just 39 (that's only one of the issues).

I'd really like to know what legal argument Eli Lilly would present to get the FDA to revisit its classification criteria, or to win some kind of exception — that would be a massive disruption to the whole framework, and you'd have everyone and their brother trying to reclassify or demand the same treatment... But cash has a loud voice, so who knows 🤷

When you get right down to it, the folks who call me "honey" and "dear" couldn't care less about biologic versus not, and neither will I lol.
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Their reasoning is that since a second chain is attached to the 39 chain backbone, it ought to be counted. Clearly they believe there's a chance, otherwise they wouldn't be putting money into it, but a win doesn't look probable. For them it's probably a low risk, high potential reward attempt, yet I'm with you that it doesn't seem likely to happen.
 
BBA1969 said:

Zuul said:

They have the freedom to set any price they want. But they're in for a rude awakening once they realize US insurers won't pay for it, and customers in Europe and the UK—who typically cover private prescriptions themselves (unless they go gray)—don't have endless money to spend.
Click to expand...

Across much of the EU, using GLP-1 drugs for weight loss remains largely stigmatized. On top of that, the cost is prohibitive because insurers refuse to pay unless a person already has diabetes.

Many physicians from older generations won't prescribe these medications to patients who are merely overweight, absent any comorbid condition. If no comorbidity exists, the topic never even comes up.

My sister-in-law, age 47, has a BMI nearing 40. Her doctor prescribed sartans and statins and never brought up GLP-1s. He did warn her that she must shed weight immediately or she will head directly into type 2 diabetes.

The twisted irony is that should she develop diabetes, suffer a heart attack, or get cancer, her health insurance (Belgium) would then cover everything.

Lilly had better run some awareness campaigns in the EU!
Click to expand...
That matches what I went through. My primary care doctor suggested Victoza, so I began using it (Ozempic couldn't be found in stock back then). Then in 2024 I saw a diabetologist, and he said he didn't believe in GLP-1 agonists.

It's still far too common for doctors to make patients feel guilty.
 
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