22 companies' Dapagliflozin+Sitaglipin were approved

As the first combination drug, competition among competitors is fierce even before its launch in 2023

DongKoo Bio has obtained a number of drugs that are the same as the new diabetes drug "Dapagliflozin+Sitagliptin" approved on the 23rd of last month.

 

A large number of consignment items produced by Dongkoo Bio have entered.

 

Dapagliflozin+Sitaglipin is a new combination complex that has never been released before, but competition has become inevitable as many pharmaceutical companies have secured it even before its launch.

 

On the 4th, the MFDS approved 22 items combined with Dapagliflozin+Sitaglipin.

 

Licensed pharmaceutical companies are Aprogen, Aju, PharmGen Science , NBK Pharm, Jin Yang, Dae Hwa, Myung Moon, GC Pharma, Dongkwang, Lite pharm tech, Binex, SCD Pharm, Daewoo, Kukje, Shinpoong, Ilyang, Reyonpharm, Ildong, Yungjin Pharm, Hana, Guju, and Sinil.

 

All of these items are commissioned and produced by DongKoo Bio.

 

DongKoo Bio is said to have shared the permit data with them.

 

DongKoo and consignment companies signed contracts before July when the so-called "consignment biological equivalence limitation 1+3" system was implemented, so 22 companies were able to obtain permission this time.

 

If the contract was made after the system was implemented, DongKoo could share product data with only three companies and produce consignment.

 

Dapagliflozin (Forxiga) is an SGLT-2 inhibitory diabetes treatment and has recently grown rapidly in the diabetes treatment market.

 

AZ's Forxiga, the original drug, recorded 18.3 billion won in outpatient prescriptions (based on UBIST) in the first half of last year.

 

Sitagliptin (Januvia) is a DPP-4 inhibitory drug that has long been leading the market.

 

MSD's Januvia recorded 21.2 billion won in outpatient prescriptions in the first half of the year.

 

The domestic pharmaceutical industry expects that both ingredients will generate a lot of sales if they are developed as a complex because they are widely used in medical sites and frequently combined prescriptions.

 

Both ingredients cannot be sold to the market before September 2023 because their material patents have not expired.

 

In addition, domestic insurance authorities have not yet established a salary standard for a combination of SGLT-2 and DPP-4 components.

 

However, it seems that many consignment companies have participated in the approval in advance because it is difficult to hold new products if there are expectations for success and the consignment biological equivalence restriction system is implemented.

 

Two days before Dongkoo Bio's product was approved, Daewon Pharmaceutical received its first approval for Dapacombi (Dapagliflozin+Sitagliptin).

 

It is said that Daewon is considering the exclusive launch.