'Symbenda' withdraws from Korean market 3 years after reimb.

The drug, which took 7 years from approval to reimbursement, will be discontinued from market

Drug price cut earlier this year with the introduction of its generics…Eisai “agreement with the original developer has expired”

A blood cancer drug that took 7 years from approval to reimbursement is being removed from the market only 3 years since starting its sale in earnest.

 

The company that sells the product has pointed to the termination of their agreement as to the cause of its market withdrawal, however, the analysis is that profitability has declined due to drug price cuts following the introduction of generic drugs earlier this year.

 

According to the Ministry of Food and Drug Safety, Eisai Korea withdrew its license for ‘Symbenda inj.

 

(bendamustine hcl.)’ on the 27th.

 

The withdrawal comes after 10 years since its approval in May 2011.

 

The drug is used to treat blood cancers such as lymphoma and chronic lymphatic leukemia.

 

The drug, which was approved 10 years ago, has only been sold in the market for around 3 years.

 

Symbenda was finally approved for reimbursement 7 years after its approval in September 2018, as combination therapy with rituximab.

 

With the reimbursement, a price cap of 283,793 won per 100mg vial was set for the drug.

 

According to IQVIA, the drug sold 2.5 billion won and 2.2 billion won in 2019 and 2020, respectively.

 

Analysts have said that Symbenda’s performance as a new anticancer drug that finally received reimbursement after 7 years was below than expected.

 

Moreover, the drug’s price has been cut in April this year by 30% with the introduction of its generics and set at 198,655 won per 100mg vial.

 

After Boryung Pharmaceutical received the first approval for Symbenda’s generic in November last year, Samyang Holdings and Handok Teva followed into the market with their Symbenda generics.

 

Boryung Pharmaceutical has started selling its first Symbenda generic with reimbursement in April.

 

Eisai Korea, the seller of Symbenda in Korea, notified the MFDS that it would discontinue the supply of Symbenda in April, a month before Handok Teva received the approval for Symbenda’s third generic in May.

 

At the time, Eisai explained, “With the expiry of the partnership agreement that was made between Eisai and the original developer of Symbenda due in October 2021, the company had made the necessary decision to discontinue supply Symbenda in Korea.” The company expected that the 100mg dose will be discontinued in July and the 25mg dose in August.

 

The company added that “Many drugs with the same ingredient that was approved for the same indications are being sold in the market and are available as a replacement for Symbenda.

 

Therefore, the discontinuation of Symbenda’s supply will not affect patients’ treatments.

 

The industry believes that the lower-than-expected performance and the decline in profitability due to the introduction of its generics were what made it difficult for the company to continue on the business in Korea, rather than the two companies'' agreement expiry.

 

With the original’s withdrawal from the Korean market, competition between the three bendamustine generics that are left in the markets and is expected to intensify to compete in filling the original's gap.