Samsung Bioepis has secured a long-term supply foundation for its rare disease therapy 'SB12' (active ingredient: eculizumab) in Brazil, the largest pharmaceutical market in Latin America.
The company said Tuesday that it signed a partnership agreement with the Brazilian Ministry of Health for the local supply of SB12.
SB12 is a biosimilar of 'Soliris' and received product approval from ANVISA, the drug regulatory agency under the Brazilian Ministry of Health, in December 2024. It is used to treat rare diseases such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
Under this agreement, Samsung Bioepis plans to exclusively supply SB12 to the Brazilian eculizumab market, estimated at approximately 250 billion won (170 million dollars), for 10 years starting next year. During this period, it will also provide technology transfer to local partners.
This agreement was made through the Brazilian government's PDP (Productive Development Partnership) system. The PDP is a framework that requires overseas pharmaceutical companies to form tripartite partnerships with local pharmaceutical firms and state-owned research institutions, combining technology transfer with product supply.
The company will maintain its cooperative relationship by partnering with local pharmaceutical company Bionovis and state-owned research institution Bahiafarma.
This is the company's third PDP contract in Brazil, following 'SB4 (Enbrel biosimilar)' in 2019 and 'SB3 (Herceptin biosimilar)' in 2020. The cumulative supply volume of the previous two products has already surpassed 6 million units, demonstrating stable local supply and superior quality.
Brazil is the largest market, accounting for roughly half of the Latin American pharmaceutical market, with the original biopharmaceutical market size reaching 23 trillion won (15.6 billion dollars) as of 2024. It is also one of the fastest-growing regions among the top 10 global pharmaceutical markets, including the United States, China, and Germany.
Based on its supply experience with existing products, Samsung Bioepis plans to expand local partnerships and solidify a long-term business foundation.
Jung Jin-han, CS3 team leader at Salmsung Bioepis, said, "Through this contract, we have demonstrated our excellence in terms of pharmaceutical quality and manufacturing and supply stability," adding, "We will actively cooperate with local partners for the long-term development of Brazil's bio-pharmaceutical industry."
in THEBIO
