Samsung Bioepis Secures 10-Year Exclusive Supply Deal in Brazil's $170 Million Rare Disease Drug Market

Samsung Bioepis headquarters. Samsung Bioepis will exclusively supply its biosimilar to Brazil's rare disease drug market, estimated at approximately $170 million, or 250 billion won, annually, for a period of 10 years. Samsung Bioepis announced on Oct. 20 that it had signed a local partnership agreement with Brazil's Ministry of Health to supply SB12 (eculizumab), a biosimilar of Soliris. Under the agreement, the company will exclusively supply the product to the Brazilian government-led market for 10 years starting in 2027, securing a stable source of revenue. The supply arrangement will be carried out through Brazil's Productive Development Partnership (PDP) program, a government initiative aimed at fostering the country's domestic biopharmaceutical industry. Under the PDP framework, global pharmaceutical companies supply medicines in exchange for transferring manufacturing technology to local pharmaceutical companies and state-run research institutions. Samsung Bioepis plans to work with local pharmaceutical company Bionovis and state-run research institution Bahiafarma, transferring technology over the course of the contract. SB12 is a biosimilar treatment for rare diseases, including paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It received marketing authorization from Brazil's National Health Surveillance Agency (ANVISA) in December 2025, laying the groundwork for its entry into the local market. Brazil's eculizumab market was estimated at approximately $170 million in 2025. This marks Samsung Bioepis's third PDP agreement with the Brazilian government. The company began supplying SB4, a biosimilar of Enbrel, in 2019, followed by SB3, a biosimilar of Herceptin, in 2020. The cumulative volume of the two products supplied locally has already exceeded 6 million units. With the addition of SB12, Samsung Bioepis's PDP portfolio in Brazil will expand to three products. Brazil ranks among the world's 10 largest pharmaceutical markets, accounting for roughly half of Latin America's total pharmaceutical market. Its originator biologics market alone is valued at approximately 23 trillion won, making the country a major competitive market for global pharmaceutical companies. Through the latest agreement, Samsung Bioepis aims to strengthen its position in Brazil by expanding its portfolio beyond autoimmune diseases and oncology into rare disease treatments. Chung Jin-han, executive vice president of Samsung Bioepis, said, "We aim to improve access to treatment for patients with rare diseases in Brazil through a stable supply of high-quality medicines. Having demonstrated our strengths in product quality and supply reliability through this tender, we will work closely with our local partners going forward."