Samsung Bioepis secures 10-year exclusive drug supply deal in Brazil

Samsung Bioepis signed a 10-year exclusive agreement in Brazil to supply SB12, a Soliris biosimilar, to the Ministry of Health. The deal covers rare diseases including paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Beginning next year, Samsung Bioepis will work with Bionovis and Bahiafarma to supply the medicine and transfer technology to local partners.

Brazil’s National Health Surveillance Agency approved SB12 in December 2024.

The Brazilian eculizumab market was worth about $170 million, or 250 billion won, last year, according to Samsung Bioepis.

The agreement expands Samsung Bioepis’ Brazilian portfolio to three products, following SB4 supplies since 2019 and SB3 supplies since 2020.

Cumulative shipments of SB4 and SB3 to Brazil have exceeded 6 million units.

Brazil accounts for about half of Latin America’s pharmaceutical market, while its original biologic medicines market reached 23 trillion won in 2024, according to the company.

Published Oct 20, 2026 11:17 am KST

Samsung Bioepis headquarters in Songdo, Incheon / Courtesy of Samsung Bioepis

Samsung Bioepis has secured a decade-long exclusive supply deal for a rare disease treatment in Brazil, strengthening its position in Latin America’s largest pharmaceutical market while opening a new chapter in its partnership with the Brazilian government.

The Korean biopharmaceutical company said Tuesday it had signed a local partnership agreement to supply SB12, a biosimilar of Soliris with the active ingredient eculizumab, to Brazil’s Ministry of Health.

SB12 is used to treat rare conditions including paroxysmal nocturnal hemoglobinuria, a blood disorder, and atypical hemolytic uremic syndrome, which can damage blood cells, kidneys and other organs.

Brazil’s health regulator, the National Health Surveillance Agency, known as ANVISA, approved the drug in December 2024.

The Brazilian eculizumab market was worth about $170 million (250 billion won) last year, according to the company, which expects the 10-year exclusive supply agreement to provide a stable source of revenue.

Under the government-led Productive Development Partnership program, Samsung Bioepis will work with Brazilian pharmaceutical company Bionovis and state-owned research institution Bahiafarma to supply the medicine and transfer technology to local partners during the contract period, which begins next year.

The agreement expands Samsung Bioepis’ Brazilian portfolio to three products, building on supplies of SB4, a biosimilar of Enbrel, since 2019 and SB3, a biosimilar of Herceptin, since 2020.

The company said cumulative shipments of the two existing products to Brazil have exceeded 6 million units, demonstrating its manufacturing and supply capabilities in the market.

Jin-han Jung, executive vice president and head of Samsung Bioepis’ CS3 team, said the company would work with local partners to improve access to high-quality medicines for Brazilian patients with rare diseases and support the long-term development of the country’s biopharmaceutical industry.

Brazil accounts for about half of Latin America’s pharmaceutical market, while its market for original biologic medicines reached 23 trillion won in 2024, according to the company.

This article was published with the assistance of generative AI and edited by The Korea Times.

三星生物制剂公司与巴西卫生部签署了一项为期十年的独家协议，向其供应Soliris生物类似药SB12。该协议涵盖阵发性睡眠性血红蛋白尿症和非典型溶血性尿毒综合征等罕见病。从明年开始，三星生物制剂公司将与Bionovis和Bahiafarma合作，向当地合作伙伴供应该药物并进行技术转让。

巴西国家卫生监督局于 2024 年 12 月批准了 SB12。

据三星生物制剂公司称，去年巴西依库珠单抗市场价值约为 1.7 亿美元，即 2500 亿韩元。

该协议将三星 Bioepis 在巴西的产品组合扩展到三种产品，此前该公司自 2019 年起供应 SB4，自 2020 年起供应 SB3。

SB4 和 SB3 向巴西的累计出货量已超过 600 万台。

据该公司称，巴西约占拉丁美洲药品市场的一半，而其原始生物药品市场在 2024 年达到了 23 万亿韩元。

发布于2026年10月20日上午11:17（韩国标准时间）

三星Bioepis总部位于仁川松岛 / 图片由三星Bioepis提供

三星生物制剂公司已获得巴西一项为期十年的罕见病治疗药物独家供应协议，巩固了其在拉丁美洲最大药品市场的地位，同时也开启了与巴西政府合作的新篇章。

这家韩国生物制药公司周二表示，已与巴西卫生部签署了一项当地合作协议，向其供应 SB12，这是一种含有活性成分依库珠单抗的 Soliris 生物类似药。

SB12 用于治疗罕见疾病，包括阵发性睡眠性血红蛋白尿症（一种血液疾病）和非典型溶血性尿毒综合征（可损害血细胞、肾脏和其他器官）。

巴西卫生监管机构——国家卫生监督局（ANVISA）于 2024 年 12 月批准了该药物。

据该公司称，去年巴西依库珠单抗市场价值约 1.7 亿美元（2500 亿韩元），该公司预计这项为期 10 年的独家供应协议将提供稳定的收入来源。

在政府主导的“生产发展伙伴关系计划”下，三星生物制药将与巴西制药公司 Bionovis 和国有研究机构 Bahiafarma 合作，在明年开始的合同期内向当地合作伙伴提供药品并转让技术。

该协议将三星生物制剂在巴西的产品组合扩大到三种产品，此前该公司自 2019 年以来一直供应恩利生物类似药 SB4，自 2020 年以来一直供应赫赛汀生物类似药 SB3。

该公司表示，其现有两款产品对巴西的累计出货量已超过 600 万台，证明了其在该市场的制造和供应能力。

三星生物制药执行副总裁兼CS3团队负责人郑镇汉表示，公司将与当地合作伙伴共同努力，改善巴西罕见病患者获得高质量药物的机会，并支持该国生物制药行业的长期发展。

据该公司称，巴西约占拉丁美洲药品市场的一半，而其原创生物药品市场在 2024 年将达到 23 万亿韩元。

本文由生成式人工智能协助发布，并由《韩国时报》编辑。