The latter situation is to allow a rise in GLP-1 compounds. State with Wegovy in June 2021 and designate a specific GLP-1 with a weight loss that has been ZEPBOUND in November 2023. A person who is now defined as a body mass index (BMI) or a person who is overweight per BMI and There is more than one weight-related health status, so you can get a GLP-1 prescription. Previously, the drug of this class was approved for FDA for type 2 diabetes. Due to the high weight loss promise on the table, the pharmaceutical company could not catch it along, the drug was insufficient, and the BAM: complexes listened to the gap.
Block so far when wegovy and zepbound are removed from the shortcoming list. Again, it will generally be a good thing. Those who take the compound version suggest that they can switch to brand options that can use the additional safety through the FDA approval process (detailed described below). But I questioned whether many people taking complex GLP-1 were actually there. Be To meet the demand, we supply enough brand drugs.
The bigger cost is a cost problem. There may be enough brand names at the moment, but it does not mean that they will be they. accessible. This drug has historically spent more than $ 1,000 without insurance (and the scope of insurance is still limited). Ellie Lily (Zepbound) and Novo Nordic (WEGOVY) has recently cut its price to $ 499 in the last month for those who don’t have insurance to choose a program to pay directly with drugmaker. In contrast, the composite option is usually about $ 200 a month.
The cost gap is why GLP-1 is made a unique situation. In general, the lack of drugs are cheap generics and are not still a patented expensive brand name. Tenille Davis, PharmdThe advocate of the pharmacy alliance speaks to SELF. Therefore, the GLP-1 complex has Technically It was operated to fill the availability space and was also resolved for price problems. Therefore, the reason for moving to cut them in recent paintings can mainly access it.
What is the difference between the combined GLP-1 drug and brand name?
As mentioned, the pharmacy complex is intended to provide some specific purposes, that is, the creation of customized drugs or some specific purposes when the supply of patients (eg, when someone needs a formulation or dosage that is not commercially made) or when it is required for a drug shortage. Considering the relatively low risk of this kind of small -scale deployment and temporary operation, the all -in -one is not able to surpass or fulfill all the regulatory hoops needed for commercial pharmaceutical manufacturers to sell their products. Michael Ganio, PharmdThe chief executive director of the Pharmacy and Quality of the American Health System Pharmacy Society speaks to SELF. As a result, there are some main differences to note about the brand name and the combined GLP-1.
Process and safety inspection
Commercial drug makers must receive a FDA approval stamp for new drug applications for all items brought to the market. To do this, research and clinical trials must be performed to prove their efficacy. Fine adjustment of dose and paths of administration; And guarantee compliance with the final product Currently excellent manufacturing process (CGMP)If applicable (for injections such as GLP-1), the drug is sterilized and usually maintains stable for several years. In contrast, the complex does not go through the FDA approval procedure for the drug and is not subject to these standards. This difference also separates complex drugs from A. general One: The latter has a weak FDA approval process (because the existing branded drug was already safe and effective), the manufacturer must still prove that the version is the same as the OG of the two fronts. There is no such director in the complex. (The brand name GLP-1 is not available as a generic because the patent has not expired. Novo Nordisk has an US patent for Semaglutide by 2032 and an ELI LILLY for Tirzepatide by 2036.)
