Is Bosutinib already on the market in China?

The original drug Bosutinib has not yet been officially launched in mainland China, so it has not been included in the National Reimbursement List or has been formally approved by the State Food and Drug Administration. The drug was developed by Pfizer and was initially approved by the US FDA in 2012 for the treatment of patients with chronic myelogenous leukemia (CML) who have failed one or more lines of treatment. It was subsequently launched in Europe, Japan, South Korea, Canada and other regions, becoming an important choice in the treatment of CML.

Due to the high price of bosutinib's original drug and the fact that it has not yet passed formal registration approval in China, domestic patients who currently need to use it usually need to obtain it through overseas pharmacies or cross-border medical channels. Common versions on the market include the European original version, the Swiss version and the Turkish version, all of which are produced under license from Pfizer. In some developing countries, such as India and Bangladesh, generic drugs are already on the market. Their active ingredients are consistent with the original drugs, their bioequivalence has been confirmed in multiple comparative studies, and their prices are relatively more affordable.

Although there are currently no original drugs on the market in China, the review of anti-tumor targeted drugs by China’s drug regulatory authorities has accelerated in recent years, and bosutinib has also been included in the list of potential introductions. In the future, if domestic pharmaceutical companies or cooperative institutions apply for registration and pass clinical review, bosutinib is expected to be officially sold in the Chinese market and included in medical insurance. It should be noted that drugs currently purchased through informal channels in China are at risk of being counterfeit, and patients purchase them through regular overseas pharmacies or qualified international medical institutions. As the treatment of chronic myelogenous leukemia gradually integrates with international standards, Chinese patients are expected to enjoy targeted treatment options that are synchronized with those overseas in the future.

Overall, although bosutinib has not yet been launched in China, its extensive global use experience and excellent efficacy have provided a positive treatment reference for domestic patients and laid a good foundation for the introduction of domestic targeted drugs in the future.

Reference materials:https://go.drugbank.com/drugs/DB06616