Goal of generic for Atozet is to be approved in next January

Chong Kun Dang is interested in direct sales.

IMD developed by Chong Kun Dang are expected to be approved in October

Atozet by MSD

Chong Kun Dang's consignment-produced hyperlipidemia combination drug 'Atozet (Atorvastatin-Ezetimibe) is known to have applied for approval this month and is aiming for approval in next January.

 

In that Atozet’s PMS by MDS will expire in next January, it is faster to acquire product approval than generics that have undergone bioequivalence testing.

 

Accordingly, it will be advantageous in terms of drug prices.

 

Chong Kun Dang recently held a meeting with 21 outsourced companies and announced plans to proceed with item approval.

 

Chong Kun Dang applied for approval of a drug with the same ingredients as Atojet, which had undergone its own clinical trial in April.

 

This drug is expected to be approved as a drug for data-based re-evaluation in October.

 

At the same time, it is expected to receive Atozet's remaining PMS (expired on January 22, 2021).

 

Prior to this, Chong Kun Dang recruited 21 consignment companies for the drug.

 

It is known that the selection of 21 companies was referred to in the order of sales of Atorvastatin formulations.

 

It is reported that on the 16th, at the consignee meeting, the details of the item permission plan were announced.

 

According to the industry, the consignment item plans to complete the application for permission this month and obtain an item approval in next January.

 

After going through the insurance payment process, it will start selling from April.

 

In this case, after the expiration of PMS in January, it will enter the market ahead of generics that apply for permission.

 

In addition, the price of drugs is expected to be higher than those of generics depending on the cascade drug prices system.

 

Chong Kun Dang's self-developed drug for data-based re-evaluation is expected to be approved in October.

 

However, it is known that Chong Kun Dang will not release it first, but will sell it at the same time as the consignment companies.

 

However, as Chong Kun Dang is currently jointly selling the original 'Atozet' with MSD, it is unclear whether Chong Kun Dang will directly release the generic.

 

Accordingly, some say that it is highly likely to pass the sale of drugs developed after Chong Kun Dang to other companies.

 

Atozet is a large-scale drug that recorded an outpatient prescription of ₩63 billion last year.

 

With Chong Kun Dang's product development and PMS expiration, it is expected to turn into a competitive system from next year.

 

However, since various interests such as drug price issues and co-promotion are complicated, it is expected that each company will have a great deal of effort in establishing strategies.