Progress on the launch of domestic generic drugs of Crizotinib

Crizotinib is one of the representative targeted drugs for ALK-positive and ROS1-positive non-small cell lung cancer (NSCLC). Since the original drug was approved for marketing in China, it has greatly improved the survival and quality of life of relevant patients. However, due to its high price, even if it is covered by medical insurance, there is still a problem of heavy payment burden for some patients. Therefore, the development and launch progress of domestic generic drugs has attracted much attention.

At present, the original version of crizotinib has been sold in the Chinese market for many years and has been included in the medical insurance catalog, which has alleviated the financial pressure on many patients. However, according to public information, the domestically produced generic version of crizotinib has not yet been officially launched and is still in the research and development or clinical trial stages. Since this drug involves complex molecular structures and synthesis processes, as well as strict requirements for quality consistency and bioequivalence, domestic pharmaceutical companies need a long period of time in the promotion process.

It is worth noting that national policies are vigorously promoting the development of domestic generic drugs, especially targeted drugs involving major diseases. In recent years, as the consistency evaluation of generic drugs has been carried out and the review of urgently needed clinical drugs has accelerated, Chinese local pharmaceutical companies have made many breakthroughs in the research and development of small molecule targeted drugs. Therefore, it is foreseeable that it is only a matter of time before domestic generic drugs of crizotinib are approved for marketing in China. Once the generic version is launched, it will further reduce drug prices and expand patient accessibility.

At present, in the overseas market, generic drugs from Bangladesh and Laos have entered the actual sales stage, and the prices are much lower than the original drugs. This also makes some domestic patients purchase drugs through formal overseas channels. However, domestic policies tend to ensure drug safety and controllable sources, so the launch of domestic generic drugs is of particular significance. If the domestic version is successfully launched in the future, it will not only promote market competition, but also alleviate the expenditure pressure on medical insurance funds.

Reference materials:https://go.drugbank.com/drugs/DB08865