On 20 October 2026, Samsung Bioepis announced that, in partnership with Brazilian state-owned pharmaceutical laboratory, Bahiafarma, and Brazilian biotechnology company, Bionovis, it has signed an exclusive partnership agreement to supply SB12, biosimilar to Alexion’s Soliris® (eculizumab), to Brazil’s universal public health system.
The agreement is formed under Brazil’s strategic Productive Development Partnership (PDP) framework. Under the PDP program, Samsung Bioepis will have exclusive access to Brazil’s public healthcare market to supply eculizumab over a 10-year period form 2027. During this period, Samsung Bioepis will also transfer technology to its local partners, enabling manufacturing in Brazil.
SB12 was approved in Brazil in December 2024 for the treatment of adults and children with PNH and atypical haemolytic uremic syndrome (aHUS). It was the second eculizumab biosimilar launched in the US (where it is marketed by Teva as Epysqli®) in April 2025, following the launch of Amgen’s Bkemv® in March 2025. Epysqli® launched in Germany, Italy and Spain in October 2023 and in Korea in April 2024.
Since 2019, Samsung Bioepis has supplied more than 6 million units of its etanercept and trastuzumab biosimilars in Brazil through the PDP program. In September 2026, Biocon entered into a supply deal with the Brazilian government to supply Bmab 1500, biosimilar to Roche/Genentech’s Perjeta® (pertuzumab) under the PDP program.