Introduction to the domestic and overseas marketing status and regulatory policies of obeticholic acid (Obeticholic)

Obeticholic Acid is a targeted drug used to treat liver diseases. It is mainly suitable for conditions such as primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH). As a farnesolX receptor (FXR) agonist, it can effectively improve liver function indicators and slow down disease progression. At present, obeticholic acid has been approved for marketing in many countries and regions, but it has not yet been officially approved by the National Medical Products Administration (NMPA) in mainland my country. Therefore, if patients want to use the drug, they still need to obtain it through overseas channels.

Abroad, obeticholic acid was developed by Intercept Pharmaceuticals and was first approved for marketing in the United States in 2016 for the treatment of PBC patients who had poor response to ursodeoxycholic acid (UDCA). Subsequently, the European Union, Japan, Canada and other countries and regions also successively approved its marketing and use. It is worth mentioning that in recent years, the drug has also been included in treatment studies for non-alcoholic steatohepatitis (NASH), and will be used in 2023, it obtained the FDA's supportive approval for the treatment of NASH liver fibrosis in n>, which has attracted widespread attention in the field of global liver disease treatment.

Although obeticholic acid is increasingly used abroad, it is still in the early stages of review in mainland China and has not been registered for marketing. If patients need to use it, they can only purchase it through regular overseas medical channels or cross-border drug purchasing platforms. It should be noted that since this drug has not yet been included in my country's drug regulatory system, you must ensure that the source is formal during the drug purchase process to avoid purchasing counterfeit and substandard drugs. At the same time, a professional doctor should conduct an evaluation before use to clarify the indications, and regularly monitor liver function and bilirubin levels.

In terms of price, there are currently two versions of obeticholic acid abroad: original drug and generic version. The price of original research drugs is relatively high, and a box can cost several thousand yuan in markets such as Europe and the United States. The price of the generic version produced by Mylan Pharmaceuticals in India is affordable, usually less than 1,000 yuan. The ingredients of the drug are basically the same as the original drug, and they have been approved for marketing by the local drug administration department. For patients who need to take long-term medication, generic drugs provide a more realistic choice in terms of economy, but they also need to be used safely under the guidance of a doctor.

Reference materials:https://www.drugs.com/