Samsung Bioepis, a subsidiary of Samsung Epis Holdings (0126Z0), will supply a rare disease treatment to Brazil, the largest pharmaceutical market in Latin America, over the next decade.
Samsung Bioepis said on the 20th that it had signed a local partnership agreement to supply SB12, a biosimilar of Soliris whose active ingredient is eculizumab, to Brazil's Ministry of Health. SB12 treats rare diseases including paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It won marketing approval from ANVISA, the health regulator under Brazil's Ministry of Health, in December 2024.
Under a Productive Development Partnership (PDP) agreement with the Brazilian health ministry, Samsung Bioepis will supply the drug in cooperation with Bionovis, a local drugmaker, and Bahiafarma, a state-run research institution. The company plans to supply the product to Brazil's government-led market for 10 years starting next year and to transfer technology to its local partners during that period.
Brazil is the largest pharmaceutical market in Latin America and ranks among the world's top 10, accounting for about half of the region's total market. The market for original biologic drugs there reached 23 trillion won ($15.6 billion) in 2024. The Brazilian market for eculizumab, the active ingredient in SB12, was worth about 250 billion won last year.
"We will contribute to improving access to medicines for rare disease patients in Brazil through a stable supply of high-quality drugs," said Chung Jin-han, vice president and head of the CS3 team at Samsung Bioepis. "Through this bid, we demonstrated our strengths in drug quality and in the stability of our manufacturing and supply, and we will work closely with our local partners."
The agreement expands the number of products Samsung Bioepis supplies to Brazil to three. The company has supplied SB4, a biosimilar of Enbrel, since 2019 and SB3, a biosimilar of Herceptin, since 2020, both under PDP agreements. Cumulative supply of those products has topped 6 million units.