Samsung Bioepis will supply a rare disease treatment to Brazil, Latin America's largest pharmaceutical market, over the next 10 years. The deal expands the company's product lineup in the country, where it has now secured 10-year long-term supply contracts for an autoimmune disease treatment, a cancer drug and the rare disease therapy.
Samsung Bioepis said on the 20th that it signed a Productive Development Partnership (PDP) agreement with Brazil's Ministry of Health to supply SB12, a biosimilar of the rare disease drug Soliris. SB12 treats rare conditions including paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), and won marketing approval in Brazil in 2024.
Under the PDP program, a global drugmaker, a local Brazilian pharmaceutical company and a state-run research institute form a three-way partnership in which production technology is transferred over a set period while the product is supplied. Samsung Bioepis will work with local drugmaker Bionovis and state-run research institute Bahiafarma to supply the product for 10 years starting next year. Medicines supplied under PDP agreements are distributed to patients through Brazil's Unified Health System (SUS).
The contract raises the number of products Samsung Bioepis supplies to Brazil to three. The company has been supplying SB4, a biosimilar of the autoimmune disease treatment Enbrel, since 2019, and SB3, a biosimilar of the cancer drug Herceptin, since 2020, both under PDP agreements. Cumulative supply of the two products has surpassed 6 million units.
Brazil is Latin America's largest pharmaceutical market and ranks among the world's top 10, accounting for about half of the region's total market. Its market for original biologics was estimated at 23 trillion won ($15.6 billion) in 2024. The Brazilian market for eculizumab, SB12's active ingredient, was worth about 250 billion won last year.
A company official said the agreement will "contribute to improving access to medicines for rare disease patients in Brazil through a stable supply of high-quality drugs." The official added that the company "demonstrated excellence in drug quality and manufacturing and supply stability through this bid, and will actively cooperate with local partners."