Atozet’s generics are approved

Generic consignment items are required according to the licensing regulations

Including companies such as Yuhan, Daewoong, and Ildong in generic companies, focused on the lowest price listed

Atozet

Generics for Atozet (Ezetimibe/Atorvastatin, MSD Korea) were approved on the 18th.

 

Dongkoo Bio, which had joined the Chong Kun Dang group, was also approved.

 

It is reported that Dongkoo Bio transferred and acquired the existing licensed items and newly licensed generic for Atozet according to the license regulations.

 

On the 18th, the MFDS approved a number of generic drugs of Ezetimibe/Atorvastatin.

 

All of them are products that have been tested for bioequivalence using the original drug Atozet as a reference drug, and are products that were applied for approval on January 23, after re-examination.

 

Pharmaceutical companies such as Yuhan, Daewoong, and Ildong are included.

 

It also included Dongkoo Bio, Jinyang, and Dasan, which conduct bioequivalence tests and commission production to other companies.

 

In particular, Dongkoo Bio attracted attention.

 

Dongkoo Bio has been preparing generic drugs and recruiting consignment companies, but was detested from consignment companies as they suddenly entered the data submission drug group preoccupied by Chong Kun Dang.

 

In January, Dongkoo Bio’s Atoeve was approved, the same ingredient, through data sharing with Chong Kun Dang.

 

However, Dongkoo Bio transferred Atoeve to Hwail, and Dongkoo Bio’s Jetstan, generic for Atozet, was approved.

 

Kuhnil, Young Poong, and TDS pharm have succeeded in obtaining approval for generics manufactured by Dongkoo Bio.

 

It is known that the approval regulations of the MFDS were affected by Dongkoo Bio's transfer of the existing licensed items to other companies and the approval of generic products.

 

This is because in order for the consignment bioequivalence item to be proved bioequivalence, the consignment item must also obtain permission.

 

Dongkoo Bio had a plan to obtain approval for its own products early through Chong Kun Dang Group, and to produce only consigned items for direct development generics.

 

This is because if Dongkoo Bio joins Chong Kun Dang Group, it will be possible to receive preferential treatment at drug prices over generics by entering within 20 of the same ingredients under the stepped drug price system.

 

However, it is said that it was impossible due to the regulations of the MFDS.

 

Under the current stepped drug price regulation, if more than 20 identical drugs are listed, the upper limit of newly listed items is reduced to 85% of the existing lowest price.

 

Generics for Atozet already have more than 20.

 

Therefore, the drug price is also determined according to the lowest price item that applied for the drug price in January.

 

Generic companies are worried about whether there will be a data-submitted pharmaceutical company that has intentionally listed the drug price at a low price so that competitors have applied for a lower drug price.

 

Regardless of this, the market is concerned about overheating competition as dozens of Atozet’s generics are pouring out.

 

Usually, when the competition for generics is severe, illegal rebates have also been on the rise.