Chong Kun Dang generic to open Atozet generic market

The Korean company applies for approval on CKD-391 in April with individually conducted clinical trial data

Only after January when the original PMS expires, other competing generics can apply for approval

Chong Kun Dang already acquired accounts for the generic through original co-marketing deal

MSD Korea

As Atozet’s post-marketing surveillance (PMS) expiration is approaching in next year, Chong Kun Dang is closely eyeing on the follow-on drug market.

 

While many of Atozet (atorvastatin plus ezetimibe) generic makers are currently developing evidences like bioequivalence test to seek approval after Jan.

 

22 next year when the original’s PMS period ends, Chong Kun Dang has already submitted an approval application to the Korean health authority by providing data from individually conducted clinical trial.

 

According to the pharmaceutical industry sources on July 17, Chong Kun Dang has completed clinical trial and requested Ministry of Food and Drug Safety (MFDS) in last April to approve an atorvastatin plus ezetimibe combination drug candidate ‘CKD-391’ as a dyslipidemia treatment.

 

MSD Korea’s original Atozet shares the same combination of atorvastatin and ezetimibe.

 

The PMS period for Atozet is to expire on next Jan.

 

22.

 

And Korean pharmaceutical companies are preparing for the approval application procedure on their generics.

 

MFDS has already approved 28 bioequivalence tests to compare the equivalence with the original Atozet.

 

However, the generics can apply for the item approval only after the original’s PMS is concluded.

 

Korea’s PMS system not only monitors post-marketing safety managements, but also protects the original’s detailed information.

 

Chong Kun Dang’s CKD-391 has been in development since 2015 and it applied for approval early, as a generic with individual clinical trial data can be approved, regardless of the original’s PMS.

 

If CKD-391 were to receive the government’s green light, the outstanding period of Atozet PMS would be invested to the generic.

 

And depending on the date of the approval, Chong Kun Dang’s generic would likely to exclusively enter the follow-on drug market.

 

As the other Atozet generics are expected to apply for approval from January next year, the government-approved Chong Kun Dang follow-on drug would be released to the market first and engage with prospective accounts as soon as possible.

 

In 2016, Chong Kun Dang signed the Atozet co-marketing deal with MSD Korea.

 

The Korean company with the well-established accounts list for the dyslipidemia treatment market would easily lead the generic market.

 

Chong Kun Dang’s approach is similar to Hanmi Pharmaceutical’s Rosuzet taking over the rosuvastatin plus ezetimibe combination drug market.

 

After licensing the rights over ezetimibe, Hanmi Pharmaceutical was able to release the rosuvastatin plus ezetimibe combination drug six months earlier than any other competitors in Korea.

 

Currently, the hyperlipidemia combination drug market is topped by Hanmi Pharmaceutical’s Rosuzet and MSD Korea’s Atozet.