Is it true that the world’s first generic version of liver cirrhosis drug obeticholic acid is on the market?

Obeticholic acid (Obeticholic acid) is an important FXR agonist. Since its original drug Ocaliva was approved in the European and American markets, it has quickly become one of the standard drugs for the treatment of primary biliary cholangitis (PBC). Although the drug has been widely used clinically overseas, it has not yet been officially launched in mainland China, which has also caused some patients to be concerned about the availability and legality of its global generic version.

At present, pharmaceutical companies from India, Bangladesh, Laos and other countries have successfully developed and put on the market generic versions of obeticholic acid. These generic drugs are highly consistent in chemical composition with the original products, and their efficacy is theoretically comparable. However, whether they are completely equivalent still requires strict bioequivalence testing.

Take Beacon Pharmaceuticals of Bangladesh, Mylan Pharmaceuticals of India and ASEAN Pharmaceuticals of Laos as examples. These companies have become the main supply sources of generic obeticholic acid drugs in the Asia-Pacific region. The price of these generic drugs is significantly lower than that of the original products, with each box selling for roughly several hundred to one thousand yuan. The specific price varies depending on the place of production, channels, and exchange rate fluctuations. Especially in the context of growing cross-border medical needs, many patients obtain generic drugs through overseas direct mail and other methods.

Therefore, although the launch of the world's first generic obeticholic acid is a fact and provides an affordable option for some patients, whether to use it still needs to be carefully weighed. If patients consider purchasing overseas generic drugs, they must go through legal and reliable channels and formulate a treatment plan under the guidance of professional doctors. At the same time, we also look forward to the early completion of registration and listing of obeticholic acid in China in the future, so that more PBC patients can obtain high-quality, regulated treatment options.

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