Will Briviact become the next Vimpat? Generics near early listing

Generic drugs of 7 companies, including Chong Kun Dang, Daewoong, Samjin, pass DREC review

Same situation as Vimpat, where the reimbursed market lacks the original drug

Attention is focusing on whether generics will be listed first in the reimbursement market, in which the third-generation epilepsy treatment Briviact (brivaracetam) failed to enter.

If 7 generic manufacturers, including Chong Kun Dang, Daewoong Pharmaceutical, and Samjin Pharmaceutical, secure reimbursement listing, competition among generic companies is expected in the reimbursed market without the original drug.

Generic companies targeting Briviact’s vacancy are on the verge of securing reimbursement listing. AI-generated image.

On the 5th, the Drug Reimbursement Evaluation Committee recognized the reimbursement adequacy of 29 epilepsy treatment products containing brivaracetam from 7 domestic pharmaceutical companies.

 

Chong Kun Dang (Briveta Tab), Daewoong Pharmaceutical (Brivatop Tab), Bukwang Pharmaceutical (Bukwang Brifil Tab), Whanin Pharm (Briva Tab), Samjin Pharmaceutical (Bricetam Tab), Myung In Pharmaceutical (Buripam Tab), and Hyundai Pharmaceutical (Brilact Tab) are expected to proceed with listing procedures after price negotiations and review by the Health Insurance Policy Deliberation Committee.

 

The original product is UCB Korea's Brivact, which received domestic approval in 2019. However, it failed to secure reimbursement listing when attempting to enter the insurance market and reportedly did not submit post-marketing surveillance (PMS) data last year.

 

With its patent expiring last February, a series of generic approvals followed. Having passed the DREC hurdle, the generic versions are now on the verge of entering the reimbursement system.

If price negotiations are finalized, a unique scenario could unfold where generics secure reimbursement listing before the original drug.

Should generics gain early listing, it would mirror the case of UCB Pharma's other epilepsy treatment, ‘Vimpat (lacosamide)’.

Vimpat, which was approved in Korea in 2010, ultimately failed to obtain reimbursement listing due to pricing issues, while generic versions of companies such as SK Chemicals’ Vimsk entered the reimbursement market first.

According to the market research institution UBIST, Vimsk recorded sales of KRW 4.5 billion last year, marking 32% growth from KRW 3.4 billion the previous year. Its prescription performance has steadily increased over 4 years, from KRW 2.3 billion in 2021.

The 7 companies preparing to list brivaracetam generics are also expected to attempt market entry using the same formula.

The ultimate question is whether they can clear the drug price hurdle that the original failed to overcome.