Samsung Bioepis makes ₩199.1 bil in Q1

supported by the rising overseas sales of its biosimilars

19% increase from Q1 last year… growth rate slows somewhat

Biogen and Organon sell ₩350 bil overseas

Increases its biosimilar pipeline… receives approval for 6 biosimilars in Korea

Samsung Bioepis is off to a smooth start this year with a sharp rise in its biosimilar sales.

 

According to the Korea Financial Supervisory Service, Samsung Bioepis recorded ₩199.1 in Q1 sales this year, a 19.4% increase compared to the same quarter of the previous year.

 

Also, the company’s net profit increased 11.5% to ₩31.9 billion.

 

This is the largest amount of sales ever made by the company in the first quarter.

 

However, compared to the ₩271 billion in Q3 and ₩221.8 billion in Q4 it had made last year, the growth rate seems to have slowed down somewhat.

 

In Q3 last year, the company had recorded its largest-ever sales with the milestone it received with the approval of its biosimilars abroad.

 

In August last year, the company’s Lucentis biosimilar ‘Byooviz’ that it developed received marketing authorization from the European Commission (EC) and from the U.S.

 

Food and Drug Administration (FDA) a month later.

 

The biosimilar products developed by Samsung Bioepis have continued to show strong growth abroad.

 

Most of Samsung Bioepis’ sales are generated by overseas sales of its biosimilars.

 

Samsung Bioepis had succeeded in commercializing biosimilars of 6 original products - Enbrel, Remicade, Herceptin, Humira, Avastin, and Lucentis.

 

All its 6 products were approved in Europe, and 5 products less the Avastin biosimilar received marketing authorization in the US.

 

The 5 biosimilars of Samsung Bioepis’ raised $292,300,000 (approx..

 

₩350 billion) in sales in Q1 this year.

 

This is a 2.5% YoY increase from the $285,100,000 made in Q1 last year.

 

Biogen’s sales of Samsung Bioepis’ 3 autoimmune disease treatments recorded $194,300,000 (approx.

 

₩240 billion), and Organon also sold $98,000,000 (approx.

 

₩120 billion) with Samsung Bioepis’ 3 autoimmune disease treatments and 2 anticancer drugs.

 

Samsung Bioepis’ biosimilars are sold abroad by its partners Biogen and Organon.

 

Samsung Bioepis, which had been established in 2012, first generated sales of ₩43.7 billion in 2013.

 

Its sales then reached ₩147.5 billion with the start of its full-fledged penetration of overseas markets with its biosimilars in 2016, and have continued to grow ever since.

 

Samsung Bioepis has recorded cumulative sales of ₩3.484 trillion since its launch in 2012.

 

The company has been accelerating market penetration with a series of biosimilar products recently.

 

This year, the company plans to release its Lucentis biosimilar ‘Byooviz’ in the US market.

 

Pursuant to a global license agreement entered into with Genentech, Samsung Bioepis will have the freedom to market the drug in the United States as of June 2022, i.e., before the expiration of Genentech’s applicable SPC (Supplementary Protection Certificate).

 

The company has also been accelerating the expansion of its biosimilar pipeline in Korea as well.

 

Samsung Bioepis received approval from the Ministry of Food and Drug Safety to market Lucentis biosimilar, ‘Amelivu (ranibizumab).’ Amelivu is the first Lucentis biosimilar to be approved in Korea.

 

With Amelivu’s approval, Samsung Bioepis is now approved for a total of 6 biosimilars in Korea.

 

The company had first entered the domestic biosimilar market after receiving approval for its ‘Enbrel’ biosimilar ‘Etoloce’ in 2015.

 

In the same year, the company also received approval for its ‘Remicade’ biosimilar ‘Remaloce,’ and then for the ‘Humira’ and ‘Herceptin’ biosimilars ‘Adaloce’ and ‘Sampenet’ in 2017.

 

Last year, it also acquired approval for its ‘Avastin’ biosimilar, ‘Onbevzi.’ Its competitor Celltrion has acquired approval for the biosimilars of Remicade, Herceptin, Mabthera, and Humira.

 

The approval of Samsung Bioepis’ biosimilars in Korea is expected to lead to financial savings for the National Health Insurance.

 

In principle, the Korean drug pricing system mandates the ceiling price of original drugs to be discounted by 30% compared to its price before patent expiry with the introduction of its biosimilars.

 

Prices of original drugs and their biosimilars that are ‘items developed by Innovative Pharmaceutical Companies, equivalent companies, or domestic companies that have signed joint agreements with multinational pharmaceutical accompanies; or items that were first-ever approved in Korea; or items manufactured in Korea’ are ensured a price set at 80% of the original’s price before patent expiry.

 

Avastin’s insurance ceiling price fell with the listing of Onbevzi last year.

 

In October last year, the ceiling price for Avastin 0.1g/4mL fell 30% from ₩330,387 to ₩231,271.

 

Price of Avastin 0.4g/16mL also fell 30% from ₩1,077,531 to ₩752,746.

 

According to the market research institution IQVIA, Avastin’s sales fell 23.8% YoY in Q4 last year to record ₩22.6 billion.

 

This was a 27.2% drop from the ₩30.9 billion made in just the previous quarter, Q3 last year.