Generic drug for Lipiodol was approved

The MFDS Approves generic for Lipiodol, & unstable supply and demand will be resolved

Guerbet Korea

The generic drug of Lipiodol, a special contrast agent which was controversial due to a demand for price increase by the seller, received an item license.

 

Lipiodol may not be able to treat patients in the event of a supply disruption, since there have been no drugs of the same composition so far.

 

With the approval of the generic drug, it is expected that the anxiety problem will be solved.

 

The Ministry of Food and Drug Safety approved the Dongkook’s generic for Lipiodol (Iodized oil; ethyl esters of the iodised fatty acids of poppy seed) on 11th.

 

This product was made by Dongkook Pharmaceutical, which has a high market share in the contrast medium market.

 

Similar to Lipiodol, it is used for lymphography, salivary gland imaging and transarterial chemoembolization (TACE) in liver cancer.

 

Lipiodol's supply disruption happened in 2018.

 

At that time, Guerbet Korea, which sells Lipiodol, applied for drug price adjustments that said supply could be stopped if price increases were not premised due to a surge in overseas demand.

 

At that time, the patient groups condemned Guerbet Korea for proceeding with drug price negotiations by taking patients as hostages, and the MFDS reviewed the emergency introduction (import through Korea Orphan & Essential Drug center without permission) in preparation for the supply disruption.

 

In the end, however, the government raised the price of Lipiodol.

 

The drug price was set at ₩190,000/10mL, which was more than three times higher than the previous August (₩52,560/10mL).

 

There was no drug to replace Lipiodol, and It was essential medicine for patients with liver cancer.

 

Yong-ik Kim, chairman of the NHIS, who concluded the drug price negotiations at the time, said, “We set the price at a much lower level than that suggested by the pharmaceutical company.

 

Supply is also expected not to be difficult in the next few years”.

 

Contrary to government evaluations, some criticized the fact that some raised their hands on the domineering of pharmaceutical companies that dominate the market.

 

Lipiodol currently has no patents registered with the MFDS.

 

As such, Dongkuk Pharm has no hurdles in selling generic drugs after the listing.