10 years of the global launch of K-biosimilars

Export of 4 types of Celltrion similars for 10 years from 2013 9 trillion won

Samsung Bioepis, cumulative sales of 4.3 trillion won since the first sales in 2013

The cumulative exports of biosimilar products developed by Celltrion and Samsung Bioepis recorded 13 trillion won.

 

Celltrion's Remsima is rapidly expanding its territory 10 years after entering the European market.

 

Celltrion's biosimilars posted cumulative exports of 9 trillion won, and Samsung Bioepis' overseas sales of more than 4 trillion won.

 

◆Celltrion Health, accumulated exports of 9 trillion won by selling 4 similar types since 2013 According to the Financial Supervisory Service on the 22nd, Celltrion Healthcare's four biosimilars, Remsima, Remsima SC, Truxima, and Herzuma, posted a total of 1.71 trillion won in exports.

 

It increased by 9.2% from the previous year and broke the record for the largest export.

 

Celltrion Healthcare is an affiliate of Celltrion, and Celltrion Healthcare Holdings is the largest shareholder (24.3% stake).

 

Celltrion Healthcare receives antibody biosimilar products from Celltrion and sells them to global distributors.

 

Celltree Healthcare is selling four biosimilars in overseas markets: Remsima, Remsima SC, Truxima, and Herzuma.

 

Remsima is a biosimilar product of Remicade.

 

Remsima SC is a subcutaneous formulation of Remsima.

 

Truxima and Herzuma are biosimilar products of anticancer drugs Mabthera and Herceptin, respectively.

 

Last year, Remsima recorded the largest export of 859.3 billion won.

 

It increased by 6.1% from 809.6 billion won in 2021 and produced the most exports since obtaining European permission in 2013.

 

Despite intensifying competition in biosimilars, Remsima continues to increase exports as more than 100 countries obtained item approval last year.

 

Remsima recorded exports of 145.3 billion won in 2013, and the cumulative amount of exports for 10 years until last year totaled 5,163.1 billion won.

 

Remsima SC exported 236.9 billion won last year, more than double the previous year's 89.6 billion won.

 

With only two products, Remsima and Remsima SC, the joint venture achieved 1.96 trillion won in exports last year.

 

Remsima SC made its first export of 34.8 billion won in 2020 and recorded a cumulative export performance of 361.4 billion won over the past three years.

 

Truxima showed exports of 436.5 billion won last year, down 4.9% from the previous year.

 

It is the second consecutive year of decline since recording 786.8 billion won in 2020.

 

It is analyzed that the growth rate has slowed somewhat as the competition for biosimilars intensified.

 

Truxima posted its first export of 383.2 billion won in 2017 and achieved a total of 2.6148 trillion won in overseas sales over the six years until last year.

 

Herzuma's export volume last year was 181.7 billion won, down 13.9% from the previous year.

 

After posting overseas sales of 211 billion won in 2021, the growth trend has slowed down.

 

Herzuma recorded a cumulative export performance of 865.6 billion won from 2017 to last year.

 

Celltrion's four biosimilars jointly exported a total of 9.49 trillion won for 10 years from 2013 to last year.

 

Samsung Bioepis is also breaking new records every year.

 

Samsung Bioepis' operating profit was 231.5 billion won, up 20.1% from the previous year, and sales were 946.3 billion won, up 11.7% from the previous year.

 

Both operating profit and sales are the highest since its launch in 2012.

 

Sales increased by 21.7% in two years from 777.4 billion won in 2020, and operating profit increased by 59.6% during the same period.

 

The operating profit to sales ratio last year was 24.5%, the highest ever.

 

Starting with the Enbrel biosimilar in January 2016, Samsung Bioepis received approval for six and five biosimilars in Europe and the US, respectively.

 

Biosimilars of five biosimilars of Samsung Bioepis, Enbrel, Remicade, Humira, Herceptin, and Lucentis, have been approved in Europe and the United States.

 

In Europe, it has additionally obtained approval for the sale of Avastin biosimilars.

 

Samsung Bioepis is selling five biosimilars in Europe and three biosimilars in the US.

 

Samsung Bioepis started selling Enbrel and Remicade biosimilars in Europe in 2016.

 

In 2018, it introduced biosimilars to Herceptin and Humira markets and started selling Avastin biosimilar AYBINTIO in Europe in 2021.

 

In the US, among the five licensed products, Remicade biosimilar RENFLEXIS was launched in the US market in 2017, and Herceptin biosimilar Ontruzant was launched in the US in 2020.

 

Last year, it started selling Lucentis biosimilar BYOOVIZ in the US.

 

Established in 2012, Samsung Bioepis generated sales of 43.7 billion won for the first time in 2013.

 

In 2016, when the biosimilar overseas targeting began in earnest, it recorded sales of 147.5 billion won, and has continued to grow every year since.

 

Since its launch in 2012, Samsung Bioepis has recorded cumulative sales of 4,311.2 billion won.

 

Most of Samsung Bioepis' sales come from overseas sales of biosimilars or royalties.

 

Domestic sales volume is negligible.

 

According to IQVIA, a pharmaceutical research institute, Samsung Bioepis' five biosimilars sold a total of 42.5 billion won last year.

 

In other words, the biosimilars of Celltrion and Samsung Bioepis have exported more than 13 trillion won in total over the past 10 years.