Samsung Bioepis signs 10-year deal to supply rare-disease drug SB12 in Brazil
In short
Samsung Bioepis said on 20 October that it signed a local partnership agreement with Brazil's Health Ministry to supply SB12 (eculizumab), a biosimilar of Soliris, for 10 years from next year. The drug treats rare diseases including PNH and aHUS. It will be the third product the company supplies in Brazil through the government's PDP scheme.
Read the full story 2 min read
Samsung Bioepis said on 20 October that it had signed a local partnership agreement with Brazil's Health Ministry to supply SB12 (eculizumab), a biosimilar of Soliris. Chosun Ilbo named Alexion Pharmaceuticals as the maker of Soliris. Asia Economy, Chosun Ilbo and Maeil Business described the arrangement as a 10-year sole supply, while Yonhap's report spoke of supply for 10 years. [ 1 , 3 , 4 , 5 ]
SB12 is used to treat rare diseases including paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). The outlets reported that it received marketing approval from Brazil's medicines agency in December 2024. Yonhap said the agency is under the Health Ministry. [ 1 , 3 , 4 , 5 ]
The contract is based on Brazil's Productive Development Partnership (PDP) scheme. Under it, according to Yonhap, global drugmakers transfer production technology to Brazilian drugmakers and research institutes while supplying products. Asia Economy described it as a scheme in which the government buys medicines from foreign drugmakers in return for technology transfer to local institutions. Chosun Ilbo said Brazil uses it to secure medicines for its public health system while building domestic production capacity, and that PDP medicines reach people through the country's unified health system (SUS). [ 1 , 3 , 4 ]
Samsung Bioepis will work with the local drugmaker Bionovis and the state research institute Bahiafarma. From next year it plans to supply SB12 to the government-led market for 10 years and to transfer production technology to the local partners during that time. Asia Economy said this follows the result of a tender. [ 1 , 3 , 4 , 5 ]
Brazil's eculizumab market was estimated at about 250 billion won ($170 million) last year. Yonhap, citing the company, called Brazil the largest pharmaceutical market in Latin America and one of the world's top 10. Maeil Business said Brazil accounts for about half of the Latin American medicines market and put its original biologics market at about 23 trillion won ($15.6 billion) in 2024. [ 1 , 3 , 4 , 5 ]
The company has supplied SB4, an Enbrel biosimilar (etanercept), in Brazil since 2019 and SB3, a Herceptin biosimilar (trastuzumab), since 2020, both through PDP contracts. Chosun Ilbo and Maeil Business said their cumulative supply has passed 6 million units. With SB12, the products supplied through PDP rise to three. Maeil Business said the company has added a rare-disease drug to its autoimmune and cancer products. [ 1 , 3 , 4 , 5 ]
Jung Jin-han (정진한), a Samsung Bioepis senior vice president, said the company would contribute to better access to medicines for Brazilian rare-disease patients through stable supply of high-quality medicines. He said the tender had proved the company's strength in quality and in manufacturing and supply stability, and that it would cooperate actively with local partners. [ 1 , 5 ]
Why it matters
The deal extends Samsung Bioepis's supply in Brazil's government-led market to a rare-disease drug, after an autoimmune drug and a cancer drug. It also commits the company to transfer technology to local partners during the contract period.
Key facts
- Samsung Bioepis said on 20 October it signed a local partnership agreement with Brazil's Health Ministry to supply SB12 (eculizumab), a biosimilar of Soliris. [ 1 , 3 , 4 , 5 ]
- SB12 treats rare diseases including paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS); Brazil's medicines agency approved it in December 2024. [ 1 , 3 , 4 , 5 ]
- The contract follows Brazil's Productive Development Partnership (PDP) scheme, with local drugmaker Bionovis and state research institute Bahiafarma as partners. [ 1 , 3 , 4 , 5 ]
- From next year Samsung Bioepis is to supply SB12 for 10 years to the government-led market in Brazil and transfer technology to its local partners during that period. [ 1 , 3 , 4 , 5 ]
- Brazil's eculizumab market was estimated at about 250 billion won ($170 million) last year. [ 1 , 3 , 4 , 5 ]
- SB12 becomes the third product the company supplies in Brazil through PDP, after SB4 (since 2019) and SB3 (since 2020). [ 1 , 3 , 5 ]
Confirmed by several sources
- Samsung Bioepis announced on 20 October a partnership agreement with Brazil's Health Ministry to supply SB12 (eculizumab), a biosimilar of Soliris. [ 1 , 3 , 4 , 5 ]
- SB12 received marketing approval in Brazil in December 2024. [ 1 , 3 , 4 , 5 ]
- The company will work with Bionovis and Bahiafarma and supply SB12 for 10 years from next year, with technology transfer to local partners. [ 1 , 3 , 4 , 5 ]
- The company has supplied SB4 (an Enbrel biosimilar) in Brazil since 2019 and SB3 (a Herceptin biosimilar) since 2020 through PDP contracts. [ 1 , 3 , 4 , 5 ]
- The earlier two products have a cumulative supply of more than 6 million units. [ 3 , 5 ]
Still unclear
- Financial terms of the contract None of the documents gives a contract value or price terms; they only give an estimate of the Brazilian eculizumab market.
- Schedule of the technology transfer The documents say transfer will take place during the 10-year period but give no milestones.