Is Osimertinib/Tagressa a domestic or imported drug? Revealing the Source and Selection of Targeted Drugs for Lung Cancer

Osimertinib/Tagrisso (Osimertinib) is a third-generation EGFR tyrosine kinase inhibitor (TKI), mainly used to treat EGFR T790M mutation-positive non-small cell lung cancer (NSCLC). Regarding its origin, osimertinib is an imported drug developed and produced by the British company AstraZeneca. It was approved for marketing in China in March 2017, becoming the first approved third-generation EGFR-TKI drug in China.

The research and development background of osimertinib stems from the resistance problems that often occur during the treatment of first- and second-generation EGFR-TKIs (such as gefitinib and erlotinib). About 55%-60% of patients will develop T790M mutation after using these drugs for 1-2 years, causing drug failure. By irreversibly binding to the EGFR protein, osimertinib not only has a strong inhibitory effect on T790M mutations, but is also effective on EGFR-sensitive mutations (such as exon 19 deletion and exon 21 L858R mutation), significantly extending the progression-free survival (PFS) and overall survival (OS) of patients.

Although osimertinib is an imported drug, its accessibility in China is relatively high. In 2018, osimertinib was included in China’s medical insurance catalog. The price after medical insurance will be reduced, which greatly reduces the financial burden of patients. At the same time, with the continuous advancement of medical technology and intensified market competition, the price of osimertinib is expected to be further reduced, allowing more patients to benefit from this advanced targeted therapy.

With the continuous development of China's drug market and the gradual relaxation of national drug approval policies, more and more domestic pharmaceutical companies have begun to try to develop targeted drugs similar to osimertinib. Although these domestic drugs have the same ingredients as osimertinib, they may have differences in production processes, clinical data and prices. Currently, there are some domestically produced EGFR inhibitors on the market. Although they are similar in mechanism of action to osimertinib, their specific efficacy and safety may be different.

Reference: https://go.drugbank.com/drugs/DB09330