Samsung Bioepis announced on the 20th that it had signed a local partnership agreement to supply SB12, a biosimilar of Soliris with the active ingredient eculizumab, to Brazil’s Ministry of Health, serving Latin America’s largest pharmaceutical market.
SB12 is a treatment for rare diseases including paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). In December 2024, it received marketing authorization from Brazil’s National Health Surveillance Agency (ANVISA), which operates under the Ministry of Health.
Brazil’s eculizumab market was valued at approximately $170 million last year. By securing an exclusive product supply agreement for 10 years, Samsung Bioepis expects to establish a stable revenue stream in the market.
Through a Productive Development Partnership (PDP) agreement with Brazil’s Ministry of Health, Samsung Bioepis will supply the product in partnership with local pharmaceutical company Bionovis and state-owned research institution Bahiafarma.
The PDP program was introduced by the Brazilian government in 2008 to foster the country’s domestic biotechnology industry. Under the system, global pharmaceutical companies supply medicines while transferring manufacturing technology to local pharmaceutical companies and state-owned research institutions. Medicines supplied through the program are distributed to the public through Brazil’s Unified Health System (SUS).
Under the results of the latest tender, Samsung Bioepis plans to supply the product to Brazil’s government-led market for 10 years starting next year and transfer technology to its local partners during that period.
Samsung Bioepis has supplied SB4, an Enbrel biosimilar containing etanercept, to Brazil through a PDP agreement since 2019, and SB3, a Herceptin biosimilar containing trastuzumab, since 2020. The company has delivered more than 6 million units cumulatively, demonstrating its product competitiveness and supply capabilities.
With this PDP agreement, Samsung Bioepis will increase the number of products it supplies to Brazil to three, further strengthening its position in Latin America’s largest pharmaceutical market and diversifying its product portfolio.
“We will work to improve access to medicines for Brazilian patients with rare diseases by ensuring a stable supply of high-quality treatments,” said Jung Jin-han, vice president and head of Samsung Bioepis’ CS3 team. “We will actively cooperate with our local partners to contribute to the long-term development of Brazil’s biopharmaceutical industry.”