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Samsung BioLogics Starts Pilot Production of Biosimilars Developed by Samsung Bioepis
Based on Experience as CMO
Samsung BioLogics Starts Pilot Production of Biosimilars Developed by Samsung Bioepis
  • By Choi Mun-hee
  • August 22, 2018, 12:08
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Samsung Biologics started on the pilot production of biosimilars “Benepali” and “Flixabi” early this month.
Samsung Biologics has started a pilot production of biosimilars “Benepali” and “Flixabi,” which were developed by its affiliate Samsung Bioepis. 

Samsung BioLogics has started the production of biosimilars for the first time since its foundation. After earning global competitiveness and trust in the contract manufacturing organization (CMO) market, it has decided to jump into production of biosimilars two years ahead of its initial plan.

According to the industry on August 21, Samsung Biologics started a pilot production of biosimilars “Benepali” and “Flixabi” early this month. The two autoimmune disease treatments were developed by its affiliate Samsung Bioepis. The pilot production will be done in Samsung Biologics’ No. 1 and No. 2 factorie located in Songdo, Incheon, and the official commercial production will start in the second half of next year.

It is the first time since its foundation in 2011 that this CMO-focused company has its hands on biosimilar production. Until recently, Samsung Biologics has focused on contract production of 17 original biomedicines from 12 multinational pharmaceuticals, such as Roche, BMS, and Sun Pharma. Samsung Bioepis has been outsourceing the production of its successfully developed biosimilars to its joint venture partner Biogen, which has a factory in Denmark.

Industry watchers say that Samsung BioLogics’ biosimilar production indicates it has won recognition from global big pharmaceutical companies for its competitiveness.

Samsung BioLogics states in the semi-annual report recently submitted to the Financial Supervisory Service that the amount of CMO contracts it has received since its foundation totaled US$3.478 billion (approximately 3.9 trillion won). Out of the total, US$787 million (approximately 880billion won) has been executed, while the remaining US$2.69 billion (approximately 3.2 trillion won) worth of order backlog will be carried out until 2019. Because CMO contracts are normally made in a 10-year unit, Samsung Biologics is expected to supply biosimilars to Bioepis for at least 10 years.