The company signed a partnership agreement with Brazil's Ministry of Health to supply SB12, a biosimilar of Alexion's Soliris (eculizumab).
Biosimilars are near-identical, lower-cost versions of biologic drugs. Brazil's health regulator, ANVISA, approved SB12 in December 2024.
SB12 treats paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two rare blood disorders. Brazil's eculizumab market was worth about $170 million last year, according to the company.
The contract was awarded under Brazil's Productive Development Partnership (PDP) program. Brazil launched the program in 2008 to build up its biotech industry, granting global drugmakers supply rights in exchange for transferring production technology to local partners.
Samsung Bioepis will work with local drugmaker Bionovis and state-run Bahiafarma.
The deal brings Samsung Bioepis' lineup in Brazil to three products.
Under earlier PDP contracts, the company has supplied SB4, a biosimilar of Enbrel, since 2019, and SB3, a biosimilar of Herceptin, since 2020, shipping more than 6 million units in total.
"We will contribute to improving access to treatment for patients with rare diseases in Brazil by providing a stable supply of high-quality medicines," said Chung Jin-han, a vice president at Samsung Bioepis.
AJP Takeaways
- Samsung Bioepis said on Oct. 20, 2026 it will be the sole supplier of SB12, its biosimilar of the rare blood disease drug Soliris, to Brazil's government-run market for 10 years starting in 2027.
- Brazil's market for eculizumab, the active ingredient in Soliris, was worth about $170 million in 2025. The contract was awarded under Brazil's Productive Development Partnership program, which trades supply rights for technology transfer.
- SB12 is the third Samsung Bioepis biosimilar supplied to Brazil, after SB4 (Enbrel) and SB3 (Herceptin). Cumulative shipments of those two have topped 6 million units.
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