Humira with sales of 100 billion won

Biosimilar market share 12%

The adalimumab market in the first quarter was 24.5 billion

10% increase from the previous year

Samsung Epis/Celltrion Humira biosimilar to be released from 2021

In the autoimmune disease treatment drug ‘Humira’ market, biosimilar products are not showing remarkable activity in the early stages.

 

Although it has been two years since domestic companies penetrated the market, the market share of ‘Humira’ biosimilar has passed two years, but the market share was only 12%.

 

It is analyzed that the price of original drugs and biosimilars did not show an explosive rise because the insurance price was similar.

 

According to IQVIA, a pharmaceutical research institute on the 7th, the market for adalimumab ingredients in the first quarter was 24.5 billion won, up 9.8% from 22.3 billion won in the same period last year.

 

Adalimumab is a TNF-alpha inhibitor that treats autoimmune diseases such as rheumatoid arthritis and psoriasis.

 

AbbVie's Humira is the original drug.

 

Humira posted sales of 104 billion won in 2019, 91.2 billion won in 2021 and 85.8 billion won last year, respectively.

 

Samsung Bioepis and Celltrion released Humira biosimilars in 2021 and last year, respectively.

 

The adalimumab market showed a moderate upward trend after falling 24.9% from 27.5 billion won in the first quarter of 2021 to 20.7 billion won in the second quarter.

 

The sharp decline in sales in the second quarter of 2020 was due to a reduction in drug prices following the entry of biosimilars, which reduced the size of the market.

 

When Samsung Bioepis listed Humira biosimilar Adaloche as a benefit in May 2021, Humira's upper limit also fell a month later.

 

As of June 7, 2021, Humira's insurance cap has been reduced by 30%.

 

The price of three drugs, Humira Pen 40mg/0.4mL, Humira Prefilled Syringe 40mg/0.4mL, and Humira 40mg vial, fell 30% from 411,558 won to 288,091 won, and Humira Prefilled Syringe 20mg/0.2 mL went down from 224,002 won to 156,801 won.

 

Humira has maintained sales at a similar level after drug price cuts following biosimilar registration.

 

Sales of Humira in the first quarter of last year were 21.5 billion won, up 1.5% from the same period last year.

 

It increased by 4.0% from 20.7 billion won in the second quarter of 2021, right after the drug price cut.

 

This means that sales volume has decreased due to drug price cuts, but sales since then have maintained the previous year's level.

 

Analysts say that the pace of market penetration of biosimilar products is slow.

 

In the first quarter of last year, Adalloce of Samsung Bioepis and Yuflyma of Celltrion posted a total of KRW 3 billion in sales.

 

Adalloce and Yuflyma posted sales of 2.6 billion won and 400 million won, respectively.

 

Adalloce posted its first sales of 400 million won in the third quarter of 2021 and exceeded 1 billion won in the first quarter of last year.

 

Adalloce's sales in the first quarter of this year increased by 134.7% compared to the same period last year, but its share in the adalimumab market was only 10.6%.

 

Adalloce's domestic sales will be handled by Yuhan Corporation.

 

Yuflyma posted sales of 200 million won in the third quarter of last year, and sales in the fourth quarter of last year and the first quarter of this year were only around 300 million won.

 

Celltrion Pharmaceuticals is in charge of the domestic sales of Yuflyma.

 

The sales share of Adalloce and Yuflyma in the adalimumab market in the first quarter was 12.2%.

 

It exceeded 10% for the first time in the fourth quarter of last year and recorded 12.5%, but this year it has decreased somewhat.

 

The market share recorded two years after biosimilar penetration is analyzed as a disappointing report card.

 

The upper price of Adalloce PFS 40mg/0.4ml and Yuflyma 40mg/0.4ml is KRW 244,877 each, and the gap between the drug price of Humira PFS 40mg/0.4ml and Humira Pen 40mg/0.4ml of KRW 288,091 is only 15.0%.

 

In principle, under the domestic drug price system, biosimilars can receive up to 70% of the original drug price before the patent expires.

 

From October 2016, up to 80% of products are guaranteed for 'items developed by a company that has entered into a joint contract between an innovative pharmaceutical company, an equivalent company, a domestic pharmaceutical company and a foreign company, or items for which Korea is the first licensed country or items produced in Korea.

 

When biosimilars are released for original drugs whose patents have expired, insurance prices are automatically reduced to 70-80% of the previous level.

 

Even if biosimilars are listed at a price that is 30% cheaper than the price of the original drug before the patent expires, it is not easy to secure price competitiveness as the drug price of the original drug is also reduced.

 

There is also an analysis that medical staff and patients have no choice but to prefer new drugs from multinational pharmaceutical companies that have accumulated reliability for a long time in a situation where drug prices do not differ greatly due to the nature of autoimmune disease drugs used for severe diseases.