Janssen, granted permission to import advanced bio medicines

It seems that it is in a hurry to introduce cell and gene therapy such as CAR-T in Korea

Janssen Korea has obtained the second approval for the import business of advanced bio medicines after Novartis Korea.

 

Janssen is also expected to introduce related products in the near future because advanced bio-medicine items designated by the MFDS can only be approved if it is approved for the advanced bio-medicines import business.

 

On the 18th, the MFDS approved Janssen Korea as an advanced bio-medicine importer.

 

Advanced bio-medicine is a new category of medicines created when the Advanced Regenerative Medicine and Advanced Bio-medicine Safety and Support Act was enacted and enforced in August last year.

 

Cell and gene therapy mainly belong to advanced bio medicines.

 

Existing cell and gene therapy drugs have been approved by the Pharmaceutical Affairs Act, but a separate management system has been established in accordance with the new law.

 

All items approved as new items after the enforcement of the law are Novartis products.

 

Previously, Novartis was the only importer to obtain advanced bio-medicine import license.

 

Novartis has been approved for Kymriah, the No.

 

1 domestic CHIMERIC anti-gen receptor-T cell (CAR-T), as well as Zolgensma and Luxturna.

 

All of these are expensive and "one-shot" treatments that can be treated with one use.

 

Attention is currently being paid to benefit negotiations in that it is a new concept of medicine and is being sold at high prices.

 

Janssen is also expected to rush to introduce related products in Korea as it has acquired a high-tech biopharmaceutical import business this time.

 

Janssen is in the process of overseas listing of products such as "Cilta-cell," a CAR-T treatment that treats multiple myeloma.

 

The MFDS designated the drug as a rare drug in August last year.

 

It is also developing gene therapy for rare retinal diseases.

 

Luxturna, approved by Novartis, is also a gene therapy that treats rare retinal diseases.

 

As Novartis preoccupies advanced bio-medicine in Korea, Janssen is also preparing for approval.

 

With the gradual introduction of advanced biomedics overseas in Korea, serious discussions on drug prices and follow-up management seem to be needed.