Generic drugs without originals released in KOR

Reflects Korea’s market characteristics…companies launch generic versions of drugs that do not have originals available in Korea

Original drugs Otexla and Vocinti withdrew from Korea’s market

Generic versions of the drugs attempt reimbursement listing in Korea

Takeda

Generic versions of drugs whose original versions are unavailable in Korea are expected to be released one after another.

 

This is becoming a Korean phenomenon, where original drugs withdraw from the domestic market due to low drug prices and generics fill the void.

 

According to industry sources, the National Health Insurance Service has begun negotiations for the reimbursement of a generic version of Otezla (Apremilast).

 

Otezla is Amgen's treatment for psoriatic arthritis and psoriasis, which was approved in November 2017 but withdrawn from the market in June 2022.

 

The drug had difficulty being listed for reimbursement.

 

The drug had become the top-selling oral psoriasis treatment in the global market but was not even properly showcased in the Korean market due to the reimbursement hurdle.

 

The analysis is that the drug missed its prime reimbursement time while changing hands three times, from Celgene, BMS, to Amgen.

 

In the meantime, competitors such as Cosentyx, Stelara, Skyrizi, and Taltz entered the reimbursement market, weakening Otezla’s competitiveness in the domestic market.

 

In Korea’s situation, as the price of the later entrants is set lower than their competitors, the pharmaceutical company’s concerns have deepened.

 

In addition, with the patent’s expiry date approaching and the domestic generic companies’ patent challenges against Amgen, the company announced Otezla’s withdrawal from the market.

 

As a result, generic products without original versions are on the verge of receiving reimbursement in Korea.

 

The drugs are: Dong-A ST’s Oteria Tab, Daewoong Pharmaceutical's Apsola Tab, Chong Kung Dang's Otebell Tab, Dongkoo Bio Pharm’s Otemila Tab, and Han Lim Pharm’s Psopre Tab.

 

In October, the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service (HIRA) held a review on the adequacy of Otezla generics and determined that their reimbursement was adequate if their price was less than the assessed value.

 

As a result, the pharmaceutical companies accepted a price lower than the assessed value and moved on to the negotiation stage with the NHIS.

 

Now that they have accepted the assessed value and moved on to the negotiation stage, it is expected that the products will be launched with reimbursement in the first half of next year at the latest.

 

Takeda’s P-CAB class gastroesophageal reflux disease drug ‘Vocinti Tab (vonoprazan fumarate)’ is also expected to be the first generic product to enter the reimbursement market without an available original drug.

 

This is because generic development by domestic pharmaceutical companies is in full swing, and Vosinty withdrew its license on the 12th.

 

Generic companies are aiming for an early market launch by avoiding Vosinty’s patent.

 

The product patent for Vosinty Tab expires in December 2027, but it can be released in October next year if the patent’s extended term is invalidated through patent avoidance.

 

Vosinty also has missed the golden time for reimbursement in Korea.

 

It is analyzed that it lost its competitiveness as domestic pharmaceutical companies' P-CAB class products such as K-CAB and Fexuclue Tab were first released on the domestic market.

 

An industry official said, “U generic companies have the advantage of greater flexibility in drug pricing because their drug development cost is relatively low.

 

They can enter the domestic health insurance market with a relatively lower price than the original companies, Therefore, it will be interesting to see how generic drugs without original drugs perform in the domestic market.