Simulect in supply crisis with no alternative

Leaves liver transplant patients with no other induction therapy option in peril

Expected to be out of stock by mid-January next year due to API supply and demand

Novartis "will complete the change of our API manufacturing site as soon as possible"

Simulect Inj (basiliximab, Novartis Korea), which is used as an induction therapy to prevent immune rejection in organ transplant patients, is expected to run out of supply in Korea due to issues in securing the supply the drug’s active pharmaceutical ingredient.

 

In particular, there is no alternative drug for liver transplantation, increasing the need for the government’s prompt response.

 

Novartis Korea reported to the Ministry of Food and Drug Safety on the 8th that the company expects a supply shortage due to the lack of global supply of the API for Simulect Inj.

 

Due to the API issue, the amount scheduled to be imported in September will not arrive.

 

As a result, the company expects the remaining stock to run out by mid-January next year based on the current inventory.

 

Simulect is a leading induction therapy drug used to prevent immune rejection during organ transplantation.

 

It is reimbursed for kidney, heart, liver, lung, small bowel, pancreas, and pancreatic islet transplants.

 

The company noted that while hospitals and transplant centers may be able to reschedule living donor transplants, which account for approximately 70% of all transplants, in the short term, a shortage of Simulect could result in changes in the physical condition of the donor and recipient during the delay, which could affect the outcome of the transplant and result in the postponement of all other scheduled surgeries.

 

The company added in the case of the rest - the 30% deceased donor transplants - timing is critical due to the nature of the donor, so the surgery must be performed quickly, and as surgery is nearly impossible without induction therapy, both the organ donation and the surgery may be rendered impossible.

 

The problem is liver transplants.

 

There are currently no other approved or available drugs for induction therapy for liver transplants, although around 1,500 cases are performed per year.

 

In the worst-case scenario, liver transplants could become unavailable.

 

Novartis plans to accelerate the approval of its new finished product manufacturing site.

 

By the end of August, it could begin shipping products manufactured in Italy.

 

However, domestic approval has not been granted for imports from that plant yet.

 

"As the new manufacturing site can be put into producing finished products upon approval of the plant change request, we will work to minimize the supply shortage period through various measures, including efforts to accelerate the approval of the request.” In March, Simulect was also hit with a three-month import suspension when it recalled products due to possible glass particle contamination in the attached ampoules.

 

However, the company responded quickly and did not disrupt supply.

 

However, as this is a global API supply issue, if the administrative process of replacing the manufacturing plant is delayed, domestic supply and demand instability is deemed inevitable.

 

This is why appropriate support from regulatory agencies such as the Ministry of Food and Drug Safety is necessary.