"Viread generic have saved KRW 400B in drug cost over 9 yrs"

Drug approval-patent linkage system…first attempt at conducting a long-term impact assessment this year

CKD's 'Diquabel Eye Drops' showed the highest drug substitution impact

It has been reported that market entries of 84 generics, which obtained priority marketing authorization, for 12 pharmaceuticals listed between 2015 and 2023 have saved medication costs of KRW 804.2 billion.

 

Specifically, it lowered the listed pharmaceutical costs by KRW 536.3 billion and saved through drug substitution by KRW 267.9 billion, totaling KRW 804.2 billion worth of medication cost cuts.

 

Sales from fourteen generics totaled KRW 397.3 billion, accounting for 49.4% of the total reduction in medication cost.

 

Among these generics was 'Tefovir Tab,' a Viread generic with priority marketing authorization and showed the highest price impact over the past nine years.

 

Generics that were introduced between 2015 and 2023 have resulted in savings of KRW 804.2 billion in medication cost

These figures were included in the '2024 Pharmaceutical Drug Approval-Patent Linkage System Impact Assessment (organized by Lee Myung-hee, Researcher at Korea Institute of Intellectual Property),' presented by the Ministry of Food and Drug Safety (MFDS).

 

As Pharmaceutical Drug Approval-Patent Linkage System Impact Assessment is conducted every year, the long-term impact assessment was conducted for the first time this year to overcome the limitations of the previous impact assessment.

 

The previous impact assessment evaluated the priority sales period spanning nine months.

 

The research team suggests that such evaluation results in a loss of information because pharmaceuticals falling into the criteria typically enter the market 1-2 months after the priority sales period.

 

The long-term impact assessment involves sales-banned items and priority marketing authorization items.

 

However, sales-banned items have been excluded from the long-term impact assessment to enhance the protection of pharmaceutical patents and to solve patent disputes between patent holders and pharmaceutical companies with generics before the launch of generics.

 

The assessment involved pharmaceuticals subjected to impact assessment from 2016 to 2021.

 

Two generic groups (12 listed pharmaceuticals and 84 generics) that generated the highest sales each year, totaling 58 generics with statements of financial position by NICE Information Service.

 

Yearly medication cost savings from

Gilead Science Korea's 'Viread,' a listed pharmaceutical that entered the market with priority marketing authorization.

 

Its price decreased from KRW 4,850 to KRW 4,727 in April 2018, then to KRW 4,677 in September 2018, KRW 3,275 in December 2018, KRW 2,505 in November 2019, and finally KRW 2,403 in January 2022.

 

Viread generics' market share significantly rose during the priority sales period.

 

Their market share was 55.6% in October 2021, recording KRW 466.1 billion in medication cost savings from reducing Viread tab price (KRW 397.2 billion) and drug substitution with generics (KRW 68.9 billion).

 

It was reported that Chong Kun Dang's 'Diquabel Eye Drops,' a generic version of 'Diquas Eye Drops 3%,' showed the most substitution impact.

 

Diquabel Eye Drops' market share began to rise during the priority sales period, reaching 90.8% by December 2022, ultimately substituting the listed pharmaceutical Diquas Eye Drops.

 

Yearly medication cost savings from Diquas Eye Drops 3% and Pazeo 0.7% Eye Drops (unit: KRW 1 million)

Over the six years, it saved a medication cost of KRW 100.2 billion from the price cut of Diquas Eye Drops 3% (KRW 3.7 billion) and generics substitution (KRW 96.2 billion).

 

This outcome resulted from the patent victory of six pharmaceutical companies, including Chong Kun Dang, producing The research team determined that "Such an outcome indicates that medication cost savings during the priority sales period may be significant factors for market share in the long-term." Yearly long-term impact assessment included 'Amosartan' in 2015, 'Stalevo Film Coated Tab' in 2016, 'Iressa Tab' and 'Pletal SR Cap' in 2017, 'Viread' and 'Layla Tab' in 2018, 'Diquas Eye Drops 3%' and 'Pazeo 0.7% Eye Drops' in 2019, and finally 'Alitoc Soft Cap' in 2020.