The difference between generic and genuine giritinib

Gilteritinib is a drug used to treat certain types of leukemia. There are some differences between generic drugs and genuine products. Genuine giritinib was developed and approved by the original drug company, Astellas Pharma, whose ingredients have been carefully researched and verified. Generic drugs are produced by other companies after the patent protection period has expired and their ingredients should be similar but not identical to the original drug.

The production process of genuine giritinib is overseen and quality controlled by the original drug company, and clinical trials were conducted to prove its safety and effectiveness before approval. The production process of generic drugs also needs to comply with relevant regulations and standards, and is subject to supervision by regulatory agencies, but the degree of supervision may be different from that of the original drug company. It is usually required to provide certain bioequivalence data to prove that it has similar drug concentration and effect in the body with the genuine product. Generic drugs should comply with relevant regulations and standards and be approved by regulatory agencies before they can be sold on the market.

The original drug of giritinib has been launched in China, but it has not yet been included in the medical insurance. The price of each box of 40mg*42 tablets may be more than 20,000 yuan, and the price of the Hong Kong version of the original drug is about 90,000 yuan per box. The price of the European version of the original drug, 40mg*84 tablets, per box listed overseas is around RMB 210,000 (the price may fluctuate due to exchange rates), which is very expensive. Generic drugs of giritinib are currently produced and sold overseas. For example, the price of 40mg*84 tablets per box produced by a Laos pharmaceutical factory is more than 4,000 yuan (the price may fluctuate due to the exchange rate).