Samsung Bioepis said Tuesday its consortium with Bionovis S.A. and Bahiafarma was selected to supply eculizumab exclusively to Brazil’s public health system for 10 years, with production technology to be transferred locally.
The agreement covers Sistema Único de Saúde (SUS), Brazil’s public health system and a major purchaser of the medicine. The Health Ministry spent more than 947 million reais (about $171 million) on eculizumab in 2025, its highest expenditure on a specialty medicine, according to IQVIA data cited by Samsung Bioepis. That spending preceded the newly announced supply arrangement.
Samsung Bioepis’s SB12 is a biosimilar of an existing eculizumab medicine. Agência Nacional de Vigilância Sanitária (ANVISA) approved it in December 2024 for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. One disorder involves the early breakdown of red blood cells; the other can damage kidneys and produce blood clots. Samsung Bioepis said SUS covers the original eculizumab treatment for paroxysmal nocturnal hemoglobinuria alone.
Brazil’s Health Ministry approved the group’s local production proposal in 2025. Its official decision names Bahiafarma, Bionovis S.A. and Samsung Bioepis as participants in the eculizumab project. Brazil’s Productive Development Partnership program, introduced in 2008, pairs public purchasing with technology transfer intended to develop domestic drug manufacturing. Under this agreement, production responsibilities are to move to the Brazilian partners in stages.
The deal adds a third product to Samsung Bioepis’s Brazilian public supply business. Its combined shipments of two earlier biosimilars, etanercept and trastuzumab, through the government program have exceeded 6 million units, the company said. Samsung Bioepis said the new partnership is intended to expand access to rare disease treatment and support local manufacturing.
Samsung Bioepis will initially provide SB12 to its Brazilian partners for distribution through SUS. The company plans to begin those shipments in 2027.
