Samsung Bioepis will exclusively supply a rare disease treatment in Brazil, the largest pharmaceutical market in Latin America, for the next 10 years.
On October 20, Samsung Bioepis announced that it has signed a local partnership agreement with the Brazilian Ministry of Health to supply the biosimilar of Soliris (ingredient name: eculizumab), known as 'SB12'. SB12 is used to treat rare blood disorders such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), and it received approval from Brazil's National Health Surveillance Agency (ANVISA) in December 2024.
The market size for eculizumab in Brazil was approximately $170 million (about 250 billion won) last year. Starting next year, Samsung Bioepis will supply SB12 exclusively to the government-led market in Brazil for a decade, ensuring stable revenue.
This agreement was made under Brazil's Production Development Partnership (PDP) system, which was introduced in 2008 to foster the domestic biopharmaceutical industry. Under this system, global pharmaceutical companies supply medications on the condition that they transfer production technology to local pharmaceutical firms or state research institutions. The supplied medications will be provided to patients through Brazil's public healthcare system (SUS). Samsung Bioepis will collaborate with local pharmaceutical company Bionovis and the state research institution Bahia Farma to supply the product while also facilitating technology transfer.
Since 2019, Samsung Bioepis has supplied the Enbrel biosimilar 'SB4' and the Herceptin biosimilar 'SB3' to Brazil under PDP contracts, with cumulative supplies exceeding 6 million units. With this new contract, the number of products supplied in Brazil will increase to three.
Jung Jin-han, head of Samsung Bioepis' CS3 team, stated, "We will contribute to improving treatment accessibility for rare disease patients in Brazil by providing high-quality medications reliably."
Meanwhile, Samsung Bioepis' parent company, Samsung Episis Holdings, is set to announce its third-quarter earnings on the 28th. Analysts predict that Samsung Bioepis' third-quarter revenue will rise significantly to 489.3 billion won, up from 392.2 billion won in the second quarter, reflecting delayed revenue from the second quarter and milestone payments of about 7.6 billion won related to the extension of European rights for the Remicade biosimilar 'SB2'.
* This article has been translated by AI.
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