9 bepotastine besilate antihistamines listed for reimb

First sustained-release drugs to be listed for reimbursement in Korea

CMO is Dongkoo Bio&Pharma...Insurance ceiling price set at KRW 326

Improved convenience from twice-a-day to once-a-day administration

Leading bepotastine besilate product

Sustained-release antihistamine drugs that contain bepotastine besilate will be listed for reimbursement for the first time in Korea.

 

The original bepotastine besilate product developed by Mitsubishi Tanabe Pharma Corporation is Tarion.

 

Tarion was sold by Dong-A ST in 2004 in Korea, and the company withdrew from the Korean market in December 2017 after the drug’s patent expired.

 

Therefore, only its generics that contain the same ingredients and salt-modified products are currently being sold in the Korean market.

 

According to industry sources on the 21st, 9 sustained-release antihistamine products will be listed for reimbursement at a ceiling price of KRW 326 from March 1st.

 

Companies that own related products are the CMO Dongkoo Bio&Pharma, and Mother’s Pharmaceutical, Eden Pharma, Yungjin Pharm, Kukje Pharma, Shin Poong Pharm, Hutecs Korea Pharmaceutical, Myungmoon Pharm, and Union Korea Pharm.

 

This is the first time a sustained-release product that contains bepotastine besilate was listed, and currently ninety-two 10mg bepotastine besilate is taken twice a day, and one once-daily 5mg product is available in the market.

 

Currently, the ceiling price for all the 10mg products is KRW 148 per tablet.

 

By daily dose, the 10mg short-acting drugs cost KRW 296, which is cheaper than the sustained-release drugs, which cost KRW 326.

 

In addition to bepotastine besilate, bepotastine salicylate products that contain a different salt is also available.

 

Also, there are sustained-release products available for bepotastine salicylate.

 

5 short-acting products and 6 sustained-release products are available each.

 

The ceiling price for these drugs is also KRW 148 for the short-acting product and KRW 326 for the sustained-release products.

 

However, bepotastine besilate products have been showing better performance.

 

Among the major items, Dong-A ST’s Twolion sold the most, recording KRW 9.5 billion in outpatient prescriptions (UBIST), followed by the KRW 4.6 billion made by Daewon Pharmaceutical’s Bepostarbi, then KRW 3.2 billion by Dong Kook’s Bepotan.

 

Among the three products, Twolion and Bepostarbi are bepotastine besilate products and Bepotan is a bepotastine salicylate product.

 

Although the salt-modified sustained-release tablets did not perform so well in the market until now, as sustained-release tablets that contain the same ingredient as the original were released, attention is being paid to whether they will break the existing market structure and drive the market.

 

Antihistamines work as antagonists to excess histamine caused by antigen-antibody reactions and is used for allergic conditions and early cold treatment.

 

In the early days of COVID-19, the market size shrank with the decline in the number of respiratory patients, but last year, it was also used for COVID-19 patients, which led to an upward trend.

 

However, it is difficult for individual companies to develop their products into blockbusters.

 

Competition is fierce in the market with over 100 generics and salt-modified products, and there are several second- and third-generation antihistamines including bepotastine, therefore, it is not easy to foster one product.

 

However, even if the drugs cannot become a blockbuster, the drugs show performance continuously, therefore, industry officials expect the sustained release products can also successfully settle in the market, with sales and marketing activities.