Is Aucatzyl expensive? Can generic drugs be purchased overseas?

Aucatzyl, common name: obecabtagene Autoleucel, obe-cel) is a new type of CD19targeted CAR-T cellular immunotherapy, mainly used to treat relapsed or refractory B cell precursor acute lymphoblastic leukemia (r/r B-ALL). This therapy was approved by the US FDA in November 2024, becoming the fifth CD19 CAR-T therapy approved in the United States. It is priced at $525,000 per treatment, which is higher than other similar products, such as Gilead's Tecartus (< span>46.2USD) and Novartis’sKymriah (58USD) .

Aucatzyl’s high cost mainly comes from its individualized production process. Before treatment, the patient's T cells need to be collected, genetically modified in a production facility in Stevenage, UK, and then the modified cells are infused back into the patient. This process involves complex logistics and high production costs. However, Aucatzyl is designed to reduce the incidence of side effects by reducing the overactivation of T cells, thereby potentially reducing the need for hospitalization and intensive care, and to some extent reducing overall treatment costs.

As for overseas generic drugs, there are currently no generic drugs ofAucatzyl approved for marketing. CAR-TCell therapy faces huge challenges in the development of generic drugs due to its individualization and complex production process. Currently, only a few pharmaceutical companies in the world have obtained approval for CAR-T therapies, such as Novartis’s Kymriah and Gilead’s Yescarta.. Therefore, patients have limited ways to purchase generic drugs overseas, and there are legal and quality assurance risks.

For Chinese patients, Aucatzyl has not yet been approved for marketing by the National Medical Products Administration (NMPA). Currently, CAR-T therapies approved on the Chinese market include Kymriah and Yescarta. If patients wish to use Aucatzyl, they may need to obtain it through clinical trials or special channels. However, these approaches may involve legal, ethical, and safety risks. It is recommended that patients fully understand relevant information and make prudent decisions under the guidance of professional doctors.

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