Lilly may seek biologics designation for Retatrutide

I'm not using Reta myself, but I keep thinking about whether to pick some up at this point.. hmm, having a bit on hand seems like it couldn't be a bad idea! If I go ahead and buy, though, what's the most common size? I'd want to make the most of being able to get in on a test.
 
bamagirl26 said:

I'm not using Reta myself, but I keep thinking about whether to pick some up at this point.. hmm, having a bit on hand seems like it couldn't be a bad idea! If I go ahead and buy, though, what's the most common size? I'd want to make the most of being able to get in on a test.
When word first reached me a few months back that they were aiming for the Biologic path, my reaction was the same. I've got 5 grams tucked away in the freezer, set aside for a rainy day—or rainy years.

From what I've seen, R10 and R30 vials are the easiest to locate group tests for across most vendors. For certain vendors that get talked about here, even the larger mg vials tend to get tested on a regular basis.
 
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.

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!
Hold on—the Sartan (for blood pressure, I'm guessing things like "Telmisartan") is somewhat logical...

but the statin is ACTUAL poison as far as her body is concerned, since it drives up insulin resistance, strips CoQ10, and triggers a whole pile of metabolic chaos??

What goes through doctors' heads at times?

My GP once wrote me a prescription for Zep (BMI was 26.4 back then) purely for inflammation and Sleep Apnea benefits... It was the pens, and I never truly "filled the script" given that kind of highway-robbery pricing anyway.. (thanks to Grey/Sudo-Grey) 😌😍
 
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.
Over at The-Incretins, "David W" shares his take on what Lilly is doing strategically:

Retatrutide revolution continues

With this readout we have 3 FDA indications ready to go for retatrutide, obesity, knee arthritis, and obstructive sleep apnea. Once Transcend 2 and 3 report out later this year they’ll have enough for diabetes as well. What is really fascinating is Lilly intends to file with a BLA submission targeted for Q1 2027. BLA stands for Biologics License Application. Lilly has been battling with the FDA arguing that retatrutide isn’t just a new drug, but a new BIOLOGIC drug. Without getting into the courtroom drama, if the FDA agrees that retatrutide is a biologic it would be a longer period of market exclusivity before generics could enter the market AND would be illegal for pharmacies to compound retatrutide. That would be a massive blow to compounding/online pharmacies and would keep profits solely in Lilly’s pockets.

Click to expand...
 
oldrunnerguy said:

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?
In my view, compounding is what worries them much more. For the typical person, Gray presents a lot of hurdles: you need to figure out crypto, search through forums, tg, and discord, dodge scams, and pick up mixing and dosing. None of that is especially difficult, yet it shifts the cost-benefit calculation considerably.
 
yeddie said:

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.
Over at The-Incretins, "David W" shares his take on what Lilly is doing strategically:

Retatrutide revolution continues

With this readout we have 3 FDA indications ready to go for retatrutide, obesity, knee arthritis, and obstructive sleep apnea. Once Transcend 2 and 3 report out later this year they’ll have enough for diabetes as well. What is really fascinating is Lilly intends to file with a BLA submission targeted for Q1 2027. BLA stands for Biologics License Application. Lilly has been battling with the FDA arguing that retatrutide isn’t just a new drug, but a new BIOLOGIC drug. Without getting into the courtroom drama, if the FDA agrees that retatrutide is a biologic it would be a longer period of market exclusivity before generics could enter the market AND would be illegal for pharmacies to compound retatrutide. That would be a massive blow to compounding/online pharmacies and would keep profits solely in Lilly’s pockets.

Click to expand...
The biologic I've been on for 20 years still runs 5k every month. I'm close to reaching out to the Chinese to see whether they can produce a fusion protein that matches Enbrel.
 
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.
It's not as if Eli Lilly is blind to the insurance problem—they bring it up constantly, and it's among the main obstacles keeping tirz from becoming an even larger blockbuster. In my view, the most pressing short-term motive for seeking a biologic designation would be shutting down compounding; the broader generic consequences down the road are definitely appealing too, but right now compounding is siphoning off a huge amount of business from both Lilly and Novo. Ricks mentions this often in interviews.
 
TooGood76 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.
It's not as if Eli Lilly is blind to the insurance problem—they bring it up constantly, and it's among the main obstacles keeping tirz from becoming an even larger blockbuster. In my view, the most pressing short-term motive for seeking a biologic designation would be shutting down compounding; the broader generic consequences down the road are definitely appealing too, but right now compounding is siphoning off a huge amount of business from both Lilly and Novo. Ricks mentions this often in interviews.
Halting compounding won't alter the reality that US insurers won't pay for it, that nationalized health systems in other countries can't make the cost-to-benefit math work, and that most people simply can't cover the out-of-pocket expense themselves.
 
Zuul said:

TooGood76 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.
It's not as if Eli Lilly is blind to the insurance problem—they bring it up constantly, and it's among the main obstacles keeping tirz from becoming an even larger blockbuster. In my view, the most pressing short-term motive for seeking a biologic designation would be shutting down compounding; the broader generic consequences down the road are definitely appealing too, but right now compounding is siphoning off a huge amount of business from both Lilly and Novo. Ricks mentions this often in interviews.
Halting compounding won't alter the reality that US insurers won't pay for it, that nationalized health systems in other countries can't make the cost-to-benefit math work, and that most people simply can't cover the out-of-pocket expense themselves.
Look at it this way: this is the largest drugmaker on the planet, and its CEO keeps saying the goal is to cut what these treatments cost so more people can get them, plus insurers have to be brought into the picture. A company like that isn't going to slap on some wild, arbitrary price. It could end up costing a lot, sure, but before launch they will have poured enormous effort into figuring out the right pricing.
 
TooGood76 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.
It's not as if Eli Lilly is blind to the insurance problem—they bring it up constantly, and it's among the main obstacles keeping tirz from becoming an even larger blockbuster. In my view, the most pressing short-term motive for seeking a biologic designation would be shutting down compounding; the broader generic consequences down the road are definitely appealing too, but right now compounding is siphoning off a huge amount of business from both Lilly and Novo. Ricks mentions this often in interviews.
EL isn't losing customers to compounders. EL is losing customers to itself. What's LD pricing, around 500 per month? Sorry, I've already got a car payment, and there's no way I'm paying 500 a month for medication.
 
Should it be approved as a biologic, that decision would establish a precedent, prompting other companies to submit their own filings the same way. So here's hoping that doesn't happen.
 
Moving from research use to a finished drug product shouldn't pose an obstacle, since importing medications for personal use is permitted. All that's required is a prescription from a physician. I've been bringing in my own medications for years—1 of them is a brand-name drug costing $385 per month, and no generic version will be available for a few more years. I've been sourcing it from India (where that brand is manufactured) at $48 for 3 months. Even after the import duties introduced by Mr T and the shipping charges, the total still comes to just $74 for 3 months. Imported Reta will remain the cheaper option.
 
ghreid said:

Moving from research use to a finished drug product shouldn't pose an obstacle, since importing medications for personal use is permitted. All that's required is a prescription from a physician. I've been bringing in my own medications for years—1 of them is a brand-name drug costing $385 per month, and no generic version will be available for a few more years. I've been sourcing it from India (where that brand is manufactured) at $48 for 3 months. Even after the import duties introduced by Mr T and the shipping charges, the total still comes to just $74 for 3 months. Imported Reta will remain the cheaper option.
There's a snag I notice there: GLP medications travel as liquids—either pens or vials—rather than as freeze-dried powder, which makes transport problematic. Even when you have a valid prescription, ordering from India probably involves lengthy transit under hot ambient conditions. Compounders nearby can sidestep the transport problem by adding a cold pack to the shipment and sending it via express service.
 
spanky2026 said:

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. 😆
 
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