Samsung Bioepis secures 10-year exclusive drug supply deal in Brazil
Summary
Samsung Bioepis signed a 10-year exclusive agreement in Brazil to supply SB12, a Soliris biosimilar, to the Ministry of Health. The deal covers rare diseases including paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Beginning next year, Samsung Bioepis will work with Bionovis and Bahiafarma to supply the medicine and transfer technology to local partners.
Key Facts
- Brazil’s National Health Surveillance Agency approved SB12 in December 2024.
- The Brazilian eculizumab market was worth about $170 million, or 250 billion won, last year, according to Samsung Bioepis.
- The agreement expands Samsung Bioepis’ Brazilian portfolio to three products, following SB4 supplies since 2019 and SB3 supplies since 2020.
- Cumulative shipments of SB4 and SB3 to Brazil have exceeded 6 million units.
- Brazil accounts for about half of Latin America’s pharmaceutical market, while its original biologic medicines market reached 23 trillion won in 2024, according to the company.
Samsung Bioepis headquarters in Songdo, Incheon / Courtesy of Samsung Bioepis
Samsung Bioepis has secured a decade-long exclusive supply deal for a rare disease treatment in Brazil, strengthening its position in Latin America’s largest pharmaceutical market while opening a new chapter in its partnership with the Brazilian government.
The Korean biopharmaceutical company said Tuesday it had signed a local partnership agreement to supply SB12, a biosimilar of Soliris with the active ingredient eculizumab, to Brazil’s Ministry of Health.
SB12 is used to treat rare conditions including paroxysmal nocturnal hemoglobinuria, a blood disorder, and atypical hemolytic uremic syndrome, which can damage blood cells, kidneys and other organs.
Brazil’s health regulator, the National Health Surveillance Agency, known as ANVISA, approved the drug in December 2024.
The Brazilian eculizumab market was worth about $170 million (250 billion won) last year, according to the company, which expects the 10-year exclusive supply agreement to provide a stable source of revenue.
Under the government-led Productive Development Partnership program, Samsung Bioepis will work with Brazilian pharmaceutical company Bionovis and state-owned research institution Bahiafarma to supply the medicine and transfer technology to local partners during the contract period, which begins next year.
The agreement expands Samsung Bioepis’ Brazilian portfolio to three products, building on supplies of SB4, a biosimilar of Enbrel, since 2019 and SB3, a biosimilar of Herceptin, since 2020.
The company said cumulative shipments of the two existing products to Brazil have exceeded 6 million units, demonstrating its manufacturing and supply capabilities in the market.
Jin-han Jung, executive vice president and head of Samsung Bioepis’ CS3 team, said the company would work with local partners to improve access to high-quality medicines for Brazilian patients with rare diseases and support the long-term development of the country’s biopharmaceutical industry.
Brazil accounts for about half of Latin America’s pharmaceutical market, while its market for original biologic medicines reached 23 trillion won in 2024, according to the company.
This article was published with the assistance of generative AI and edited by The Korea Times.
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