Samsung Bioepis Enters Into Landmark 10-Year Agreement To Supply Eculizumab To The Brazilian Market, Anchoring Long-Term Growth In Latin America

• Decade-long Productive Development Partnership (PDP) for SB12 (eculizumab) to expand public access to critical rare disease treatments and support the company’s long-term growth in Latin America
• Samsung Bioepis consortium, with local partners Bahiafarma and Bionovis, selected as the sole supplier of eculizumab for 10 years
• In partnership with local entities, Samsung Bioepis to contribute to the growth of Brazil’s biopharmaceutical industry through technology transfer and local manufacturing
• Builds on the successful supply of over 6 million units of etanercept and trastuzumab to Brazil’s public health system through PDP since 2019 and 2020, respectively

Samsung Bioepis Co., Ltd. today announced a landmark 10-year agreement with its local partners in Brazil—state-level public laboratory Bahiafarma and local pharmaceutical leader Bionovis—to supply its eculizumab biosimilar, SB12, to Brazil’s universal public health system, the Sistema Único de Saúde (SUS).

Formed under Brazil’s strategic Productive Development Partnership (PDP) framework, this milestone agreement expands Samsung Bioepis’s footprint in Latin America's largest biopharmaceutical market. It also deepens the company’s commitment to the region through a consortium with key domestic public and private partners.

“We are proud to deepen our commitment to Brazil’s public health initiative by advancing partnerships for local manufacturing and contributing to improving access to high-quality medicines,” said Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets, Samsung Bioepis. “The Samsung Bioepis and local partners consortium was selected as the sole supplier of eculizumab for 10 years, and this long-term agreement is not only a testament to our product quality, manufacturing excellence, and supply reliability, but also a cornerstone for our sustained growth in Latin America. Furthermore, by diversifying our partnerships to include state-level collaborators, we are expanding our contribution to the balanced growth of the biopharmaceutical industry across regions of Brazil. We look forward to working with our local partners to contribute to the long-term development of the Brazilian biopharmaceutical industry.”

The PDP model is one of the key drivers of Brazil's national health strategy, designed to enhance the sustainability of the SUS. Introduced by the Brazilian government in 2008, the PDP scheme supports the growth of the country’s pharmaceutical industry by facilitating technology transfer from established companies in return for guaranteed purchases from the SUS. Brazil’s Ministry of Health (MoH) has been expanding the PDP initiative to include rare diseases to increase local production and expand access for rare disease patients who often face limited treatment options and costly care.

In Brazil, all citizens and residents are eligible for the SUS, and 80% of the population relies solely on the SUS for healthcare coverage.¹ While biologics represent approximately 12% of all medicinal products acquired by the SUS, they account for approximately 60% of its government spending on medicinal products.²

The incorporation of SB12 directly addresses a significant budgetary and public health challenge. Eculizumab represents the single highest-expenditure specialty medicine for the MoH, with annual public spending exceeding BRL 947 million (approximately USD 171 million) in 2025 alone.³ By delivering a clinically equivalent, cost-effective biosimilar, the 10-year PDP enables the MoH to alleviate severe budgetary strain and explore expanding access for patients who previously faced barriers to care. Currently, the reference eculizumab is covered by the SUS for only one of its approved indications: Paroxysmal Nocturnal Hemoglobinuria (PNH).

Under the PDP, Samsung Bioepis will supply the finished product to its local partners for sale to the SUS over a 10-year period from 2027. During this period, Samsung Bioepis will provide technology transfer so that manufacturing responsibilities can be gradually transferred to its local partners, enabling local manufacturing in Brazil.

SB12, Samsung Bioepis’s eculizumab, was approved by Brazil’s Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA) as a biosimilar to Soliris4 in December 2024. It is indicated for the treatment of adults and children with PNH and atypical hemolytic uremic syndrome (aHUS).

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings (KRX: 0126Z0), Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology, and neurology. For more information, visit www.samsungbioepis.com.

¹ The Commonwealth Fund. International Health Care System Profiles: Brazil. Available at: https://www.commonwealthfund.org/international-health-policy-center/countries/brazil (Accessed October 2026)

² Pontes MA, Ribeiro AA, Albuquerque FC, Leite Cotenzini SN. Comparative price analysis of biological medicines: disparities generated by different pricing policies. Front Pharmacol. 2024 Jan 11;14:1256542. doi: 10.3389/fphar.2023.1256542. PMID: 38273835; PMCID: PMC10808539.

³ IQVIA Non-Retail Brazil HPP database 2025. USD based on exchange rate as of December 31, 2025.

⁴ Soliris is a trademark of Alexion Pharmaceuticals, Inc.