Sema removed from Compounding?

[jennster]

I'm not sure if anyone has seen this yet, but now they are trying to get sema removed from compounding. They're taking a different angle with the same intentions. Ozempic compounding

 

[touringsedan]

Trying to have FDA label it is as demonstrably complex to compound would prevent all compounding. This process usually takes 12-18 months, so not anytime soon.
Glad we have research peps!

On another note, Eli Lilly is thinking ahead with Retatrutide and already filed to have it labeled as a biological, this would also prevent compounding out of the gate when it goes retail in 2026.

It's all about making all the profits. But that is why they are in the drug business.

 

[Lilith]

Trying to have FDA label it is as demonstrably complex to compound would prevent all compounding. This process usually takes 12-18 months, so not anytime soon.
Glad we have research peps!

On another note, Eli Lilly is thinking ahead with Retatrutide and already filed to have it labeled as a biological, this would also prevent compounding out of the gate when it goes retail in 2026.

It's all about making all the profits. But that is why they are in the drug business.

And yet, it is so very obviously not complex to compound. If the FDA allows the classification of Reta as a biologic, it seems they are full of it. From what I read, biological have to be derived from living cells and tissues and can’t by lyophilized in a lab, which we already know is absolutely possible.

 

[SmokeySquid]

Trying to have FDA label it is as demonstrably complex to compound would prevent all compounding. This process usually takes 12-18 months, so not anytime soon.
Glad we have research peps!

On another note, Eli Lilly is thinking ahead with Retatrutide and already filed to have it labeled as a biological, this would also prevent compounding out of the gate when it goes retail in 2026.

It's all about making all the profits. But that is why they are in the drug business.

I assume having one component of CagriSema already on the demonstrably complex to compound list, should they succeed in getting it classified as such, would make it much easier to argue the same for future products that they release.

Expect to see every trick in the book pulled out in an attempt to keep this cash cow, aka the American people, paying full price for all of their current and future products. Makes me wonder what lengths they will go to prevent people from using gray market products if enough people move over to them

 

[YoYoFat]

And yet, it is so very obviously not complex to compound. If the FDA allows the classification of Reta as a biologic, it seems they are full of it. From what I read, biological have to be derived from living cells and tissues and can’t by lyophilized in a lab, which we already know is absolutely possible.

Exactly! It’s been so easy to compound it’s been done for over two years without any issue, at least not with respect to the pharmacies following USP guidelines.

And I don’t see FDA classifying Reta as a biologic. They already rejected that request, and EL sued HHS (FDA’s parent agency) over it, and FDA is holding firm.

 

[scarywood75]

I assume having one component of CagriSema already on the demonstrably complex to compound list, should they succeed in getting it classified as such, would make it much easier to argue the same for future products that they release.

Expect to see every trick in the book pulled out in an attempt to keep this cash cow, aka the American people, paying full price for all of their current and future products. Makes me wonder what lengths they will go to prevent people from using gray market products if enough people move over to them

I doubt there's anything realistically they can do to stop China