Chong Kun Dang recruits consignment companies for Atozet

Benefit from maintaining drug prices by obtaining approval earlier than generics

It is expected in October, more than 20 companies want to participate

Atozet by MSD

Chong Kun Dang submitted an application for approval in April for Atorvastatin-Ezetimibe, generic for Atozet and recruiting consignment companies is also gaining popularity.

 

Chong Kun Dang applied for item approval of Atorvastatin-Ezetimibe through its own clinical trial.

 

Considering the maximum period of 6 months for the approval review period, it is expected around October.

 

On the other hand, generic companies must apply for approval after the expiration of Atozet's PMS on January 22, next year, so it is possible to approve product permission as early as February of that year.

 

However, if generic companies sign an entrusted production contract with Chong Kun Dang, which allows early approval, to obtain product permission, not only will the market entry be accelerated, but it will be advantageous in terms of drug price registration.

 

Only 20 companies can receive benefits.

 

According to the industry on the 18th, more pharmaceutical companies expressed their willingness to participate in the recruitment of 20 consignment manufacturers of generic for Atozet by Chong Kun Dang.

 

Chong Kun Dang started recruiting consignment manufacturers, seeing that product approval was possible within this year.

 

In particular, Chong Kun Dang's products are drugs for data-based re-evaluation that have undergone clinical trials, and are not generic drugs.

 

Therefore, the consignment licensed items produced by Chong Kun Dang become authorized generics rather than generic drugs.

 

Authorized generics can receive the highest price regardless of the conditions for DMF listing or direct bioequivalence test.

 

However, prices for generics that are applied for permission after the end of the PMS of the original drug, drop at a certain rate if they do not directly go through the bioequivalence test.

 

Currently, 29 cases have been approved for bioequivalence protocols to conduct bioequivalence tests directly with Atozet.

 

However, they can apply for permission on January 22, when PMS ends, so there is a high possibility that the approval of the item will be delayed than that of Chong Kun Dang consigned products.

 

Moreover, when the number of Chong Kun Dang commissioned production items reaches 20, the drug prices for generics that are applied for permission after the end of the PMS will drop again due to stepped pricing system.

 

For this reason, many pharmaceutical companies are expressing their intention to participate in the recruitment of Chong Kun Dang's consignment companies.

 

An industry official said, "Pharmaceutical companies that do not directly proceed or fail the bioequivalence test want a contract for consignment production with Chong Kun Dang.

 

It is known that more companies than the 20 recruitment limit already expressed their intention to participate." On the other hand, companies that have already conducted bioequivalence tests and have been successful are complaining that they may be disadvantageous in drug prices due to Chong Kun Dang's consignment companies.

 

Some say that companies of incrementally modified drugs should regulate the tricks of recruiting contractors using stepped pricing system.