Permission is increasing prior to the end of PMS

Rosuvastatin-Ezetimibe calcium products were also added to six companies in three years.

Hanmi's Rosuzet

Even before the end of PMS (Post marketing surveillance), a lot of new items have been approved through a contract production contract with the original company.

 

Since PMS system in Korea is also provided with the data protection function of the original drug, it is possible to apply for a license for the same ingredient after PMS expires.

 

However, as more and more original companies share item data in order to expand commissioned production, market competition is intensifying even before PMS.

 

According to the industry on the 3rd, 18 new drugs (6 companies) were approved for the hyperlipidemic complex (Rosuvastatin and Ezetimibe) on the 29th of last month.

 

New products have been released in about 3 years since December 2017.

 

The first licensed item for this formulation is Hanmi's Rosuzet.

 

Rosuzet was approved in June 2015.

 

Subsequently, by December 2017, 84 additional drugs with the same ingredients were approved.

 

All of these items, including Rosuzet, are drug for data-based re-evaluation, and were granted PMS until June 7, 2021, in recognition of the new combination of the two ingredients.

 

During this period, the vendor of the item should conduct a post-marketing investigation on a certain patient.

 

If post-marketing investigation is mandatory, data protection rights are also granted to prevent the generic drug of the same ingredient from applying for permission during the PMS period.

 

As expected, until June 7, 2021, the same ingredient generic cannot apply for permission.

 

However, 18 items that received this new license were commissioned and produced by the original PMS-granted original company and shared data, making it possible to enter the market.

 

In 2016, it was approved through Ajou Pharm, which has been approved for Cretrol.

 

Imported original companies do not increase their competitors.

 

However, these days, domestic companies often share it with competitors even though it is a drug that has been granted exclusive rights.

 

As for the sustained-release tablet of the indigestive drug, Mosapride citrate, PMS expires on June 29th, but 50 items of the same ingredient have already been approved.

 

The original company, Daewoong Pharmaceutical, was granted permission to share data and produce it in consignment.

 

Telmisartan, Amlodipine besylate The hypertensive complex Telmisartan-Amlodipine besylate complex also ends PMS on October 30th, but only 30 items have been approved this year.

 

This is because Ildong Pharmaceutical, one of the original companies, is a consigned product.

 

This trend is accelerating in recent years as the calculation of consignments aimed at rapidly entering the market and pharmaceutical companies seeking to increase profits by expanding commissioned production.

 

However, pharmaceutical companies that maintain the No.

 

1 market share are not happy with the addition of competitors.

 

These are Hanmi Pharm, which owns Rosuzet, and Yuhan, which has a dominant share of Duowell (Telmisartan-Amlodipine besylate) and Gastin CR (Mosapride citrate sustained release tablet).

 

Industry officials said, "This is a result of a combination of Korean development situations driven by lucrative items."