Explanation of differences between producing countries and importing countries of Crizotinib

Crizotinib (Crizotinib) was originally developed by Pfizer of the United States. It is a classic small molecule targeted tyrosine kinase inhibitor. It is mainly used to treat non-small cell lung cancer with positive ALK or ROS1 gene rearrangement. The original crizotinib was first approved for marketing in the United States and Europe. It is an imported innovative drug. It later entered the Chinese market and was approved by the national food regulatory authorities. The core research and development and earliest production systems of the original crizotinib currently used in domestic hospitals come from American pharmaceutical companies.

In the domestic market, there are both imported original research versions of crizotinib and generic versions approved by domestic companies. Imported original drugs are usually produced overseas and then sold in China. The production process and quality control system are highly consistent with international standards, and clinical data accumulation takes longer. Domestic generic crizotinib is produced by domestic pharmaceutical companies in accordance with consistency evaluation requirements after the patent of the original research expires or is licensed. The ingredients, dosage and administration methods are consistent with the original drug.

In terms of efficacy and safety, domestic generic crizotinib drugs that have passed national consistency evaluation are basically the same as imported original drugs in terms of drug composition, bioavailability and clinical equivalence, and can theoretically achieve similar therapeutic effects. The main differences are more reflected in excipients, production batch management and brand recognition. For most patients, choosing compliant domestic generic drugs under the guidance of a doctor will not significantly affect the treatment effect.

From the perspective of actual medication use, imported crizotinib is usually more expensive, while the domestic version, supported by medical insurance policies, has a relatively lower out-of-pocket ratio for patients, which helps reduce the economic burden of long-term treatment. When choosing imported or domestic crizotinib, patients should focus on whether it is a formally approved product, whether it is included in medical insurance, and their own financial affordability, and make a comprehensive judgment based on the advice of professional doctors.

Keyword tags: crizotinib,ALK/ROS1positive, non-small cell lung cancer, targeted drugs, differences between imports and domestic products, medical insurance

Reference materials:https://pubmed.ncbi.nlm.nih.gov/24756793/