Samsung Bioepis (CEO Han-seung Ko) signed a marketing partnership with Yuhan Corporation for the domestic sale of' ADALLOCE (ingredient name adalimumab)', an autoimmune disease treatment.

Adaloce is the?first in global sales?^1?)?As a biosimilar of the drug 'HUMIRA', it is the first product that has been approved for sale in Korea. It is a treatment for autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease.

Samsung Bioepis has been preparing for release through an agreement with the original drug developer ABBVIE after acquiring the domestic marketing license of Adaloche in September 2017.

Prior to the launch of Adaloce, which was planned in the first half of this year, Samsung Bioepis consulted with a number of companies to select a marketing partner, and selected Yuhan Corporation as a vendor with high expertise in the domestic prescription drug market.

Thus the Samsung Bio piece about 2,000 billion?²⁾?dwaeteumyeo to sell all of the biosimilar products in the domestic market, TNF- alpha inhibitors blockbuster three kinds (Humira, Enbrel, Remicade worth), the patient benefits utilizing the broad product portfolio I can improve it.

In addition, Samsung Bioepis is conducting domestic sales of ETOLOCE (Enbrel Biosimilar) and Remicade (REMALOCE, Remicade Biosimilar), which have been previously released, through Yuhan Corporation. Based on the contract, the cooperation between the two companies can be further strengthened.

Samsung Bioepis President Han-Seung Ko said, "We are pleased to be able to present the most widely used biosimilar products in Korea in the world. We will continue to strive to expand treatment opportunities through high-quality drugs to patients. would."?He said.

Adaloce was launched in October 2018 under the product name 'IMRALDI' in the European market, and competed in the European Humira biosimilar market by achieving cumulative product sales of $417 million (approximately 450 billion won) by the end of 2020. It is forming the leading position in

In the U.S. market, it obtained a marketing license under the product name 'HADLIMA' in May 2019, and the launch time is planned for July 2023 according to a licensing agreement with AbbVie.

On the other hand, Samsung Bioepis has developed three types of autoimmune disease treatments (SB2: Remicade biosimilar, SB4: Enbrel biosimilar, SB5: Humira biosimilar) and two anticancer drugs (SB3: Herceptin Biosimilar) since its founding in 2012. Similar, SB8: Avastin Biosimilar) was developed and sold.

In particular, according to Biogen, a marketing partner of Samsung Bioepis, the three autoimmune disease treatments (SB2, SB4, SB5) of Samsung Bioepis reached 240,000 patients in Europe from 2016 to 2020. Was prescribed to them.?³⁾

Samsung Bioepis?further strengthens its leadership in the global biosimilar industry based on?a number of real world data?⁴)?secured through these achievements,?and continues to grow while responding to unmet needs of pharmaceuticals around the world. It plans to expand the pipeline to various areas to lay the groundwork.

Since the second half of last year, Samsung Bioepis is in the process of evaluating the approval of SB11, a biosimilar for ophthalmic diseases such as macular degeneration, for sales in the US and Europe, and the follow-up pipeline SB12 (Soliless Biosimilar) SB15 (Ilia biosimilar) and SB16 (Prolia biosimilar) are undergoing phase 3 clinical trials, and SB17 (Stellara biosimilar) is undergoing phase 1 clinical trials.

¹⁾?HUMIRA's annual global sales in 2020 are about 23 trillion won ($1,983,2B) ²⁾?Sum of sales by drug substance, IQVIA data ³⁾?Source: Biogen 4Q 2020 and Annual performance presentation presentation ⁴⁾?Real-world data: Data consisting of patient health status and health management information collected from various sources