Samsung Bioepis to Exclusively Supply Rare Disease Treatments in Brazil for 10 Years

PDP agreement with the Brazilian government
Number of products supplied in Brazil rises to three

Samsung Bioepis will exclusively supply treatments for rare diseases in Brazil, Latin America's largest pharmaceutical market, for 10 years.

A view of Samsung Bioepis in Yeonsu-gu, Incheon. Samsung Bioepis

Samsung Bioepis said on October 20 that it had signed a local partnership agreement with Brazil's Ministry of Health to supply SB12 (generic name: eculizumab). SB12 is a biosimilar of Soliris used to treat rare diseases, including paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It received marketing approval from Brazil's National Health Surveillance Agency in December 2024.

As of last year, Brazil's eculizumab market was estimated at about 250 billion won ($170 million). By securing exclusive supply rights in the market for 10 years, Samsung Bioepis will establish a stable revenue base.

The agreement was made under the Brazilian government's Productive Development Partnership (PDP) program. Under the PDP, the Brazilian government requires overseas pharmaceutical companies to transfer technology to local institutions in exchange for purchasing their medicines. Samsung Bioepis will supply the product in partnership with local pharmaceutical company Bionovis and state-run research institution Bahiafarma. Subject to the tender results, the company plans to supply SB12 to the Brazilian government's market for 10 years starting in 2027 and transfer technology to its local partners over the same period.

This is not Samsung Bioepis' first PDP contract in Brazil. The company has supplied SB4 (an Enbrel biosimilar; generic name: etanercept) under the same arrangement since 2019 and SB3 (a Herceptin biosimilar; generic name: trastuzumab) since 2020. With this agreement, the number of products Samsung Bioepis supplies to Brazil will increase to three. The company plans to further strengthen its position in the local market and diversify its product portfolio through this agreement.

"We will contribute to improving access to medicines for patients with rare diseases in Brazil by ensuring a stable supply of high-quality medicines," said Jeong Jinhan, an executive director at Samsung Bioepis. "This tender has demonstrated our excellence in medicine quality and the stability of our manufacturing and supply. We will work closely with our local partners to support the long-term development of Brazil's biopharmaceutical industry."

This content was produced with the assistance of AI translation services.