'Inbosa' US Clinical Trial Resumes, Kolon Focuses on Administrative Lawsuit Domestically

[Asia Economy Reporter Cho Hyun-ui] As the phase 3 clinical trial of Kolon Life Science's osteoarthritis gene therapy 'Invossa Kiju (Invossa)' has resumed in the United States after being temporarily suspended due to ingredient controversies, Kolon Life Science plans to focus on administrative litigation related to the cancellation of domestic approval instead of reapplying for domestic product approval.

A Kolon Life Science official stated on the 13th regarding the commencement of domestic sales, "It will be decided based on the results of the ongoing administrative litigation." This means that regardless of the U.S. Food and Drug Administration (FDA)'s decision to resume clinical trials, the decision on whether to start domestic sales will be made through the ongoing administrative litigation, and the company will concentrate on this. Although some mention the possibility of reapplying for product approval for Invossa, the response will vary depending on the outcome of the administrative litigation, so no position has been finalized for the time being.

Invossa, the first gene therapy approved domestically, received approval from the Ministry of Food and Drug Safety (MFDS) in 2017. However, in March of last year, it was revealed that one of the actual ingredients was not the cartilage cells listed in the approval but kidney cells that could potentially cause tumors, leading to an immediate suspension of sales in Korea.

In July of last year, the MFDS canceled Invossa's product approval. Kolon Life Science filed a petition for cancellation of the administrative disposition and a request for suspension of effect with the Seoul Administrative Court and Daejeon District Court.

If Kolon Life Science loses the administrative litigation, even if it obtains marketing approval from the FDA, it will have to apply for new product approval domestically. An MFDS official explained, "To resume domestic sales of Invossa, product approval must be obtained again," and added, "The FDA's resumption of clinical trials cannot invalidate the MFDS's cancellation of product approval."

This content was produced with the assistance of AI translation services.