Samsung Bioepis said Tuesday it has secured a 10-year deal to exclusively supply its rare disease biosimilar SB12 to Brazil's public health system, strengthening its foothold in Latin America's largest pharmaceutical market.
The South Korean biopharmaceutical company formed a consortium with Brazilian drugmaker Bionovis and state-run laboratory Bahiafarma under Brazil's Productive Development Partnership program.
Starting in 2027, Samsung Bioepis will supply SB12, a biosimilar of the rare disease drug Soliris, for distribution through Brazil's universal public health system, SUS. The agreement also includes a phased transfer of manufacturing technology to support local production.
Brazil's PDP program, introduced in 2008, aims to secure essential medicines while developing domestic pharmaceutical manufacturing through partnerships with international drugmakers. About 80 percent of Brazilians rely exclusively on SUS for healthcare.
Eculizumab, the active ingredient in Soliris and SB12, was Brazil's highest-spending specialty medicine in 2025, with government expenditure exceeding 947 million Brazilian reais ($171 million), according to IQVIA data cited by Samsung Bioepis. The company did not disclose the contract's value.
SB12 treats two rare blood disorders: paroxysmal nocturnal hemoglobinuria (PNH), which causes premature destruction of red blood cells, and atypical hemolytic uremic syndrome (aHUS), which can cause blood clots and kidney damage.
Brazil's health regulator, Anvisa, approved SB12 for both conditions in December 2024, although SUS currently covers the original eculizumab treatment only for PNH.
The agreement expands Samsung Bioepis' presence in Brazil to three biosimilars. Since 2019, the company has supplied more than 6 million units of its etanercept and trastuzumab biosimilars through the same government program.
Jinhan Chung, vice president and head of commercial strategy for international markets at Samsung Bioepis, said the partnership would support the company's long-term growth in Latin America while expanding access to rare disease treatments and strengthening local manufacturing capabilities.
By Lim Ye-jin (yejinlim@heraldcorp.com)
