Samsung Bioepis signs 10-year rare disease drug supply deal in Brazil

Samsung Bioepis has signed a 10-year partnership agreement with the Brazilian Ministry of Health to supply SB12, a biosimilar for eculizumab, to the Brazilian market. SB12 is used to treat rare diseases, including paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). The product received marketing authorization from ANVISA in December 2024.

The agreement follows Brazil’s Productive Development Partnership (PDP) model, which involves tripartite collaborations between global pharmaceutical companies, local manufacturers, and state research institutions. Under this contract, Samsung Bioepis will supply the product starting next year and provide technology transfers to local partners, including the pharmaceutical company Bionovis and the state-run research institute Bahiafarma.

This deal expands Samsung Bioepis’s presence in Brazil, where it has previously supplied biosimilars for Enbrel (SB4) and Herceptin (SB3) through similar PDP agreements. The Brazilian eculizumab market was valued at approximately 250 billion won (170 million USD) last year. Brazil remains a major pharmaceutical hub, representing roughly half of the Latin American market.