MEDI:GATE NEWS Samsung Bioepis and Yuhan Corporation signed a domestic sales partnership with Humira biosimilar adaloce

Samsung Bioepis announced on the 15th that it has signed a marketing partnership with Yuhan Corporation for domestic sales of’ADALLOCE’, an autoimmune disease treatment drug.

Adaloce is a biosimilar of HUMIRA, the world’s No. 1 global sales drug, and is the first product that has been approved for sale in Korea, and rheumatoid arthritis is a mechanism that suppresses the expression of tumor necrosis factor (TNF)-alpha It is a treatment for autoimmune diseases such as ankylosing spondylitis and Crohn’s disease.

Samsung Bioepis has been preparing for the release through a licensing agreement with the original drug developer AbbVie after acquiring the domestic marketing license of Adaloche in September 2017. Ahead of the launch of Adaloce, which was planned in the first half of this year, consultations were conducted with a number of companies to select a marketing partner, and Yuhan Corporation, which has high expertise in the domestic prescription drug market, was selected as a vendor.

As a result, Samsung Bioepis is selling all biosimilar products in the domestic TNF-alpha inhibitor blockbuster (Humira, Enbrel, Remicade) market worth about 200 billion won, and it is possible to improve patient benefits by utilizing a diverse product portfolio. There was.

In addition, Samsung Bioepis is also selling the existing autoimmune disease treatment Etoloce (Enbrel Biosimilar) and Remaroce (Remicade Biosimilar) in Korea through Yuhan Corporation. Based on this, 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 medicines to patients. I will do it.”

Adaloce was launched in October 2018 under the product name’IMRALDI’ in the European market, and achieved cumulative product sales of $417 million (about KRW 450 billion) by the end of 2020, and the European Humira biosimilar market. It is at the forefront of the competition.

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) is 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.

Samsung Bioepis further strengthens its leadership in the global biosimilar industry based on a number of real-world data secured through these achievements, while responding to unmet needs of pharmaceuticals around the world, laying the foundation for sustainable growth. It plans to expand the pipeline to various areas to prepare.

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

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