Global lead Humira’s sales drop... biosimilars occupy 16%

Last year’s TNF-α inhibitor market shrinks 0.4% YoY

Humira’s sales drop 12% due to introduction of its biosimilars and price cuts

5 domestic biosimilars record ₩36.8 billion in sales… market shares increase slightly

The ₩200 billion autoimmune disease market has finally revealed its form in Korea.

 

The growth of the global leading product ‘Humira’ had fallen somewhat due to the introduction of its biosimilars.

 

The 5 biosimilars by domestic companies Celltrion, Samsung Bioepis, LG Chem, etc.

 

are also increasing their influence in the market, but their total market share remains in the 10% range.

 

◆ TNF-α inhibitor market shrinks for the first time… aftermath of Humira’s drug price cut According to the market research institution IQVIA on the 9th, sales in the domestic TNF-α inhibitor market was ₩233 billion, a 0.4% decrease from the previous year.

 

TNF-α inhibitors are antibody drugs that suppress the expression of tumor necrosis factor TNF alpha in the body and are prescribed for autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis.

 

Products from multinational pharmaceutical companies such as Humira, Remicade, Simponi, Enbrel, and Enbrel Myclic are leading the market, and biosimilars from domestic companies such as Celltrion, Samsung Bioepis, and LG Chem have also thrown their hats into the market.

 

This is the first year the domestic TNF-α inhibitor market’s size had shrunk.

 

The market had continued to show high growth every year since making a twofold growth in 6 years from ₩120.2 billion in 2014 to ₩233.9 billion in 2020.

 

However, the market showed sluggish growth after 2018, when it recorded a 23.2% YoY growth, then grew 11.2% and 4.5% respectively in 2019 and 2020.

 

The market turned downwards for the first time last year.

 

The recent sluggish market growth of the TNF-α inhibitor market is due to the sluggish sales of the lead product in the market - Humira.

 

Humira sold ₩91.2 billion last year, a 12.3% decrease from the previous year.

 

This is the first time Humira’s sales fell compared to the previous year.

 

Since its release in 2006, its sales rose every year to exceed ₩100 billion for the first time in 2020 but then fell to a record ₩90 billion the next year.

 

The sales decline is due to the introduction of biosimilars.

 

Samsung Bioepis had registered its Humira biosimilar ‘Adaloche’ in May last year and released it in the domestic market.

 

In principle, the insurance price cap of original drugs falls 30% with the introduction of biosimilars under the Korean drug pricing system.

 

Humira’s price had been reduced by 30% from June 7th last year.

 

With the price cut, prices of three drugs - Humira Pen inj.

 

40mg/0.4mL, Humira Prefilled syringe inj.

 

40mg/0.4mL, Humira inj.

 

40mg vial fell 30% from ₩411,558 to become ₩288,091, and Humira Prefilled syringe inj.

 

20mg/0.2mL fell from ₩224,002 to ₩156,801.

 

Humira recorded ₩27.5 billion in sales in Q1 last year but dropped 24.9% to record ₩20.7 billion in just the one quarter since.

 

Humira then made some recovery to ₩21.1 billion and ₩21.9 billion in Q3 and Q4 but wasn’t able to recover from the impact of their price cuts.

 

Sales of other TNF-α inhibitor products of multinational pharmaceutical companies such as Janssen’s Remicade and Simponi, Pfizer’s Enbrel, and Enbrel Myclic have shown a continuous increase.

 

◆ Domestically developed similars make ₩36.8 billion...

 

twofold increase in 4 years but occupy only around 10% of the market Although domestic biosimilar products are gradually expanding their market share in the TNF-α inhibitor market, their market influence is still not large.

 

Starting with Celltrion’s Remisa, domestic products such as Samsung Bioepis’s Etoloce, Remaloce, Adaloche, and LG Chem’s Eucept have currently entered the TNF-α inhibitor market.

 

Remsima and Remaloce are Remicade biosimilars.

 

Originals of Adaloche and Eucept are Enbrel.

 

Adaloche is Humira’s biosimilar.

 

Last year, sales of the 5 TNF-α inhibitor biosimilars increased 13.9% from the previous year to record ₩36.8 billion.

 

This is over a twofold increase in 4 years from the ₩18.2 billion in 2017.

 

Remsima, which first appeared in 2013, is leading the growth of biosimilars.

 

Remsima's sales last year were ₩24.4 billion, up 9.8% from the previous year.

 

Remsima’s sales decreased 12.0% from ₩25.3 billion in 2019 to ₩22.2 billion the following year, then made a rebound last year.

 

Biosimilars of Samsung Bioepis and LG Chem barely make less than ₩50 billion in annual sales.

 

Samsung Bioepis’ Etoloce recorded ₩3.9 billion in sales last year, down 0.8% from the previous year.

 

It recorded a high growth rate from the ₩700 million in 2017 to ₩2 billion in 2018, then to ₩4 billion in 2020, but then sales stalled the last year.

 

Remaloce’s sales increased 10.1% from the previous year to record ₩3.6 billion but did not significantly influence the total market.

 

LG Chem’s Eucept had also shown 30.7% growth in the market recording ₩3.6 billion in sales but did not exert much influence in the market.

 

The 5 domestically developed biosimilars in the TNF-α inhibitor market only was able to occupy 15.8% last year.

 

In 2020, its sales grew 13.8%, a slight increase, which is in stark contrast to its big success made in Europe and the US.

 

In Korea, the difference in the insured drug prices between original drugs and biosimilars is not large, therefore the latecomers cannot penetrate the market as quick as in Europe or the United States.

 

Some analysts say that it is not easy overcome the trust in original drugs with biosimilars that have been established for a long time as the drugs are used in critically ill patients.