23 new drugs approved last year with no Korean-made

14 more than nine in 2018, including two IMDs and three biosimilars

Overall number of approved finished products soared due to CMO generics

Apparently, total 23 investigational new drugs have been approved in Korea last year.

 

Compared to 2018, the number was increased by 14 but not one of them was made in Korea.

 

Moreover, two incrementally modified drugs (IMDs) and three biosimilars have been cleared.

 

According to Ministry of Food and Drug Safety (MFDS)’s pharmaceutical information website on Jan.

 

8, updated information of newly approved investigational drugs in 2019 found that total 23 drugs have been passed by MFDS last year.

 

All of them were developed outside of Korea.

 

Korean pharmaceutical companies JW Pharmaceutical, Jeil Pharm and SK Chemicals had their Hemlibra subcutaneous injection, Lonsurf tablet and Ongentis capsule approved, respectively, but all of them were developed from abroad.

 

K-CAB tablet (tegoprazan, CJ Health Care), approved on July 5, 2018, is still the latest Korean-made new drug.

 

2019 new drugs

Out of all drugs approved last year, five were biological drugs and 17 were synthetic drugs.

 

MFDS has approved two IMDs last year, including; an amlodipine besylate-chlorthalidone-telmisartan triple combination drug, True Set tablet (Yuhan), and eight items of multiple combination drugs with pitavastatin calcium and fenobirate.

 

Besides, three biosimilars—Samsung Bioepis’ Etolce 50 mg prefilled syringe (etanercept), Daewon Pharmaceutical’s Terosa cartridge injection and Pangen’s Panpotin prefilled syringe injection—were approved last year as well.

 

Meanwhile, total 4,793 finished pharmaceutical products (661 OTC, 4,132 prescription drugs) have been approved last year.

 

Compared to 2,056 products approved in 2018, year 2019 had significantly more finished products cleared.

 

The surge in approved finished products could have been because of surge in number of CMO-manufactured generics with cosigned bioequivalence test.

 

4,207 generics have been cleared in 2019, which the number doubled from 1,754 in 2018.

 

Sources analyze it was because many of the generics have applied for approval in a hurry before the cosigned bioequivalence test limiting policy came into effect.