Samsung Bioepis signs 10-year eculizumab supply deal in Brazil
Samsung Bioepis, a South Korea-based biopharmaceutical company, has been selected with Brazilian partners Bahiafarma and Bionovis as the sole supplier of its eculizumab biosimilar (SB12) to Brazil’s public health system under a 10-year agreement beginning in 2027.
The agreement falls under Brazil’s Productive Development Partnership (PDP) framework, which supports technology transfer and domestic pharmaceutical manufacturing in exchange for government purchases. Samsung Bioepis will initially supply finished product to its local partners, with manufacturing responsibilities gradually transferring to the partners over the agreement’s 10-year term, according to the announcement.
The partnership is intended to expand access to eculizumab through Brazil’s Sistema Único de Saúde (SUS), the country’s universal public health system. In 2025, public spending on eculizumab exceeded 947 million Brazilian reals, or approximately $171 million, according to IQVIA data cited by Samsung Bioepis.
Brazil’s health system currently covers the reference eculizumab product for paroxysmal nocturnal hemoglobinuria (PNH), one of the drug’s approved indications. SB12 is approved in Brazil for treating adults and children with PNH and atypical hemolytic uremic syndrome (aHUS), according to the company.
Brazil’s Health Regulatory Agency approved SB12 as a biosimilar in December 2024. Under the new agreement, technology transfer is expected to enable local manufacturing as production responsibilities shift to Bahiafarma and Bionovis.
Samsung Bioepis said the agreement builds on its previous PDP partnerships to supply etanercept and trastuzumab to Brazil’s public health system.
