Development of Recomid generics fierce despite reeval issue

Concerns remain over its reimbursement reevaluation that is in progress

5 bioequivalence tests from 4 companies were approved this year... 33 companies are attempting to avoid Recomid’s patent in Korea

Companies started out the development of their generics aware that ‘Rebamipide’ is subject to reimbursement reevaluations

Rebamipide market grows to reach KRW 140 billion per year... Recomid SR’s sales grow rapidly

Pic of Yuhan Corp

Development of generics of Yuhan Corp’s antiulcer drug, ‘Recomid SR’ (rebamipide),’ continues to remain fierce in Korea.

 

Despite the authorities’ notification of the reevaluation of rebamipide, generic companies are continuing to develop their generic versions as planned along with patent challenges.

 

The rebamipide-based antiulcer drug market has been growing rapidly recently, mainly around Recomid SR Tab.

 

This is why the industry believes that the generic companies decided to take the risk and believe that the reevaluation results will be to ‘maintain reimbursement.’ According to industry sources on the 15th, CMG Pharma received approval for a test plan to evaluate the bioequivalence of its Remipid SR tablets and Yuhan Corp’s Recomid SR tablets earlier this month.

 

Before CMG Pharma, Pharmgen Science, Dongkook Pharmaceutical, and Withus Pharm received approval for 4 bioequivalence test plans to develop their respective generic versions of Recomid SR Tab.

 

All have been approved after March this year.

 

Adding up the approvals.

 

4 companies have received approval for 5 bioequivalence test plans in the last three months.

 

One interesting aspect is that rebamipide is subject to reimbursement reevaluations this year.

 

In February last year, the government announced its plans that it will reevaluate its reimbursement of rebamipide drugs.

 

This means that all 5 bioequivalence tests for the development of Recomid generics were approved while the company was aware of the risk of 'reimbursement withdrawal’ that may arise after the reevaluations.

 

The companies have also been attempting to evade Recomid’s patent.

 

Thirty-three generic companies, including the four companies including CMG Pharma, filed a passive trial on the scope of rights against Yuhan Corp in June last year against Recomid SR’s formulation patent.

 

8 ingredients subject to reimbursement reevaluation in 2023

The industry pointed to the relevant market growth as the reason why the generic companies are continuing the development of generics for Recomid SR Tab and patent challenges despite the risk of reimbursement withdrawal.

 

According to the market research institution UBIST, the rebamipide-based antiulcer drug market grew 19.7% YoY to reach KRW 143.1 billion last year.

 

The market started to grow rapidly after the ranitidine issue arose in Q3 2019.

 

As ranitidine-based antiulcer drugs were withdrawn from the market for excess NDMA (N-nitrosodimethylamine) impurities, rebamipide-based antiulcer drugs received reflective benefits.

 

In 2020, its sales exceeded KRW 100 billion for the first time and then increased by 27.2% in 2 years until last year.

 

Recomid SR Tabs were at the center of market growth.

 

Recomid SR Tab was jointly developed by Yuhan Corp, GC Pharma, Daewoong Pharmaceutical, and Daewon Pharmaceutical.

 

The existing tablet formulation was improved into a sustained-release formulation, reducing the 3 times a dosage regimen to 2 times a day.

 

Thanks to the rapid growth of Recomid SR Tab, Yuhan Corp’s Recomid (tablet + SR tablet) has grown to become the second-largest product in the market.

 

Last year, the total prescription amount of Recomid was KRW 6.8 billion, up 61% YoY.

 

The industry estimated that about 80% of all prescriptions for Recomid came from Recomid SR Tab.

 

Companies that jointly developed and released drugs with Yuhan Corp are in a similar situation.

 

GC Pharma’s Mucotect, Daewon Pharmaceutical's ‘BIDreba’, and Daewoong Pharmaceutical's 'Mucotra' showed a 35-100% increase in prescriptions in 2022 compared to 2021, thanks to the addition of SR tablet products.

 

Quarterly antiulcer rebamipide drug market size(Unit: KRW 100 million, Data: UBIST)

An industry official said, “It seems that companies are continuing generic development in preparation for the possibility that reimbursement will be maintained even after the reimbursement reevaluation.” Judging from last year's case, the outline of the reimbursement reevaluation for rebamipide will be revealed as early as July.

 

In the case of last year, the reevaluation results were notified to the pharmaceutical companies in July, and then the authorities received objections were received for a month in August.

 

The final decision was made in November after a DREC meeting.