Are there any domestic generic drugs of Obeticholic acid? It's sunny

Obeticholic acid is a farnesoid X receptor (FXR) agonist for primary biliary cholangitis (PBC). It improves cholestasis and liver function indicators by regulating liver bile acid metabolism and anti-inflammatory pathways. In overseas markets, obeticholic acid has been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of specific PBC patients. Its launch provides a new drug option for patients who do not respond well to or tolerate traditional treatments. However, the domestic market accessibility to obeticholic acid is still very limited.

At present, obeticholic acid has not been officially approved in China, so there are no legal sales channels for generic drugs or original drugs in China. This means that patients cannot purchase the drug through domestic hospitals or pharmacies, and it cannot be included in the scope of medical insurance reimbursement. Domestic pharmaceutical companies such as Chia Tai Tianqing have not yet launched a generic version of obeticholic acid, and there is no clear timetable for its launch. For patients who wish to use obeticholic acid, clinically they can only choose drugs imported from overseas. However, cross-border drug purchase involves complex factors such as prescription requirements, transportation restrictions, laws and regulations, and they need to strictly abide by relevant regulations and use them under the guidance of professional doctors.

It is worth noting that as an FXR agonistobeticholic acid has a unique mechanism of action and directly affects bile acid metabolism and hepatocyte anti-inflammatory response, giving it potential advantages in the treatment of PBC. In the future, with the advancement of domestic drug approval and generic drug research and development, there is a possibility that obeticholic acid will be launched in China, which will provide patients with a safe and controllable treatment option. While patients are waiting for the domestic launch, they can try to keep the disease stable by optimizing the existing UDCA treatment regimen, combining lifestyle intervention and regular monitoring of liver function, and wait for the new drug to become more accessible.

Reference materials:https://en.wikipedia.org/wiki/Obeticholic_acid