Is Apalutamide a domestic drug or an imported drug and an explanation of the quality differences

Apalutamide (Apalutamide) is a new generation of androgen receptor antagonist, mainly used to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and some metastatic castration-sensitive prostate cancer (mCSPC). This drug was originally developed by the American company Johnson & Johnson (Janssen) and was the first to be marketed in Europe and the United States. It is an original imported drug. In recent years, with the acceleration of China's drug review and approval system, apalutamide has been approved for marketing in China and has been included in the medical insurance catalog, becoming one of the important drugs for the treatment of prostate cancer.

Currently, apalutamide sold in the Chinese market has both imported and domestic versions. Domestic apalutamide is produced by a number of domestic pharmaceutical companies based on the ingredients and quality standards of the original drug. It has been approved by the National Medical Products Administration (NMPA) and passed the quality and efficacy consistency evaluation. This means that the domestic version is consistent with the original drug in terms of ingredient content, drug bioequivalence, efficacy and safety, and can meet the requirements of clinical treatment.

From a quality perspective, the original drug has accumulated a large amount of real-world data in clinical research and global use, and its stability and efficacy have been widely verified. Domestic generic drugs have been on the market for a short period of time. Although they are strictly benchmarked against original drugs in terms of quality standards, their clinical use experience is relatively limited. However, the active ingredients, preparation process and in vivo metabolism characteristics of domestic apalutamide that have undergone consistency evaluation are highly consistent with imported drugs, and there is generally no significant difference in efficacy in clinical use. After using the domestic version, most patients achieve expected efficacy and tolerability.

In terms of price, apalutamide has been included in my country's medical insurance. The price after medical insurance is about more than 5,000 yuan per box, and patients can buy it at regular domestic hospital pharmacies. In foreign markets, the lower-priced Lao version of generic drugs costs about more than 2,000 yuan. Some patients may obtain them through formal cross-border channels, but they need to pay attention to the legality and safety of the source of the drugs. Generally speaking, domestic apalutamide has more advantages in price and accessibility, and its efficacy is basically the same as that of imported drugs. It is a cost-effective treatment option for most patients.

Reference materials:https://www.drugs.com/