Bill for consigned manufacture of advanced biologics

submitted for domestic manufacture of drugs like Kymriah

Rep. Hye-sook Jun submits bill to amend the Advanced Regenerative Medicine and Bio Drug Act as representative

‘To allow MFDS approved institutions to outsource manufacture drugs...Strengthen patient access and domestic foundation for advanced regenerative medicine

A bill is being promoted to allow advanced biological products such as cell and gene therapies Kymriah and Zolgensma to be manufactured by government-authorized consignment organizations and facilities.

 

The goal of the bill is to expand the domestic production infrastructure for advanced biological products to reduce the time and cost of manufacture while increasing patient access to treatments.

 

Rep.

 

Hye-sook Jun of the Democratic Party of Korea submitted a bill for the partial amendment to the ‘Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biological Products’ as representative.

 

Cell and gene therapies are highly complicated and expensive to produce as they require the harvesting of patient cells, but if developed successfully, it is highly effective in treating serious and incurable diseases and are therefore attracting attention in the global pharmaceutical market.

 

Currently, most of the cell and gene therapies used in Korea are developed by foreign pharmaceutical companies, and it takes a lot of time and money to send the patients’ cells overseas, manufacture them into therapeutic products, and then bring them back to Korea to be administered to patients.

 

If the therapies can be manufactured in Korea, it will be possible to reduce this time and cost, thereby increasing patient convenience.

 

Rep.

 

Jun explained that she saw the need for this bill in this aspect.

 

In particular, Jun pointed out that even if Korean companies succeed in developing and receiving approval for homegrown cell and gene therapies in the future, it is not realistically possible for all domestic cell and gene therapy developers to build and operate large cell processing facilities for manufacture.

 

Therefore, to encourage the development and use of cell and gene therapies in Korea, Jun explained that it is necessary to reorganize the system and allow proactive consigned manufacture of cell and gene therapies.

 

For this, Jun introduced a bill to allow advanced biological products to be manufactured on consignment by institutions and facilities authorized by the Ministry of Food and Drug Safety.

 

Jun said, "The bill aims to increase patient access to treatment by reducing the time and cost of developing cell and gene therapies as well as time to administering it to patients.

 

It also aims to expand the domestic infrastructure for the manufacture of advanced biopharmaceutical drugs."