What is the quality of imported obeticholic acid? Is there any difference?

Obeticholic acid is an original drug developed by Intercept Pharmaceuticals. It is mainly used to treat primary biliary cholangitis (PBC). Abroad, obeticholic acid has been approved and marketed in many countries, especially in markets such as the United States and Europe. Obeticholic acid has shown significant efficacy in clinical applications, helping to improve patients' bile acid levels, reduce liver damage, and delay the progression of the disease.

However, obeticholic acid has not yet been approved in the Chinese market, so domestic patients cannot purchase the drug through official channels. This forces some patients to obtain obeticholic acid through overseas drug purchase channels, especially original drugs in markets such as the United States and Europe. Imported obeticholic acid usually comes in two common specifications, namely5mg 30 tablets and 10mg 30 tablets. The price is relatively expensive, with a single box usually selling for more than 20,000 yuan (the specific price varies due to exchange rate fluctuations).

In overseas markets, the quality of obeticholic acid is strictly supervised, and its pharmaceutical ingredients, dosage and therapeutic effects all comply with international pharmaceutical quality standards. As an original drug, its quality is relatively stable and has undergone multiple rounds of clinical verification. Every link in the pharmaceutical production process must comply with the requirements of FDA, European Medicines Agency (EMA) and other international agencies, so the quality of imported obeticholic acid can be guaranteed.

However, as market demand increases, some generic versions have also begun to circulate in overseas markets. Generic drugs usually have the same active ingredients and dosage as the original drugs, but there may be certain differences in production processes, use of excipients, and packaging. The price of generic drugs is usually more affordable. A box of generic obeticholic acid drugs of the same specifications may cost between several hundred to one thousand yuan, which makes some patients choose to buy generic drugs.