SAMSUNG-BIOEPIS
Samsung Bioepis Co., Ltd. today announced its expansion into the Brazilian biopharmaceutical market. The first product available in the country is BRENZYS™ (etanercept), a biosimilar referencing ENBREL® .i BRENZYS™ was approved by Agência Nacional de Vigilância Sanitária (ANVISA), the country’s health regulatory agency, in December 2017 for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and non-radiographic axial spondyloarthritis.
Samsung Bioepis is continuing its business expansion in multiple markets across the world, including mainland China, where the company entered into partnerships with 3SBio and C-Bridge Capital to develop and commercialize multiple biosimilar candidates from Samsung Bioepis.
BRENZYS™ is being supplied to Sistema Único de Saúde (SUS), the country’s public health system, through a Productive Development Partnership (PDP) between Samsung Bioepis and local partners, Bionovis and Bio-Manguinhos/Fiocruz.
Under the PDP, Samsung Bioepis will supply biosimilar products or product intermediaries to the local partners for sale to SUS for a period of 10 years. During this period, Samsung Bioepis will provide technology transfer to the local partners, so that manufacturing responsibilities can be gradually transferred to enable local manufacturing in Brazil. The PDP scheme was introduced by the Brazilian government in 2008, in order to expand access to medicines and support the country’s pharmaceutical industry through technology transfer from established companies in return for guaranteed purchases from SUS.
In Brazil, over 75% of patients nationwide rely on SUS for health care coverage.ii While biologics represent approximately 4% of all medicinal products acquired by SUS, they account for approximately 51% of government spending on medicinal products.iii
“We are excited to provide our high-quality biosimilars to patients across Brazil, and look forward to working with our local partners to enhance patient access to high-quality healthcare. Equally important, by sharing our scientific knowledge with our local partners, we hope to do our part in contributing to the long-term development of the Brazilian biopharmaceutical industry,” said Sang-Jin Pak, Senior Vice President and Head of Commercial Division, Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and health care systems across the world.”
Samsung Bioepis’ products are now available across five continents: North America, Europe, Asia, Oceania, and Latin America. The company currently has four biosimilars approved and marketed across Europe, which include the anti-TNF trio of BENEPALI™ (etanercept), FLIXABI™ (infliximab), and IMRALDI™ (adalimumab), as well as an oncologic biosimilar, ONTRUZANT® (trastuzumab). Over 170,000 patients are currently under treatment with Samsung Bioepis’ biosimilars in Europe. In the United States, the company has one biosimilar – RENFLEXIS® (infliximab-abda) – approved and marketed. ONTRUZANT® (trastuzumab-dttb) received approval from the U.S. Food and Drug Administration (FDA) in January 2019, while ETICOVO™ (etanercept-ykro) and HADLIMA™ (adalimumab-bwwd) received FDA approval in April and July 2019, respectively.
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. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com .
_____________________________
i
ENBREL is a registered trademark of Pfizer
ii
Jurberg C, Humphreys G. Brazil's march towards universal coverage. Bull World Health Organ
. 2010;88(9):646-7.
iii
Debiasi M, et al. Biosimilars in Brazil: The Beginning of an Era of Broader Access. Journal of Cancer Therapy
. 2017; 8:814-826.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190910005444/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Libraesva and Cyber Guru Announce Strategic Combination to Create a Leading European Human-Centric Cybersecurity Provider27.1.2026 11:00:00 CET | Press release
The combination of two Italian cybersecurity leaders with strong international footprints creates a unique European player delivering an integrated portfolio of Email Security and Security Awareness Training to reduce human cyber risk end-to-end. Cyber Guru and Libraesva today announced a strategic combination that brings together two highly complementary Italian cybersecurity companies to form a new European leader in human-centric cyber protection. The combined group will offer organisations an integrated approach to defending against email-based threats, social engineering, and human-targeted attacks, integrating advanced technology with behavioural resilience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260127531600/en/ Cyber threats are evolving rapidly, with attackers focusing less on infrastructure and more on the weak link in security – human behaviour. Phishing, business email compromise, smishing, QR-code attack
Europe’s First Meteorological Infrared Sounder Reveals the Atmosphere in 3D27.1.2026 10:30:00 CET | Press release
The first images from Europe’s pioneering meteorological infrared sounder were unveiled today at the EU Space Conference in Brussels, marking a major advance in the ability to monitor how the atmosphere evolves before and during severe weather. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260127490399/en/ Full Earth disc image from the MTG-S Infrared Sounder showing a surface-temperature-sensitive channel, captured between 12:45 and 15:30 UTC on 15 November 2025. The image distinguishes land and sea surface temperatures as well as cloud-top temperatures, highlighting cloud structures and weather systems. Hot desert regions appear in red, while cold cloud tops are shown in blue. © Image: Data acquired on 15 November 2025 and processed by industrial partners Thales and OHB under the supervision of EUMETSAT and ESA. Visual produced by EUMETSAT. The images were captured by the Infrared Sounder (IRS) flying aboard Meteosat Thir
Clearwater Analytics Embeds AI into Beacon Risk Platform to Accelerate Model Validation and Exposure Analysis27.1.2026 10:00:00 CET | Press release
Production-grade AI transforms quantitative workflows—from scenario analysis to tail risk modeling—inside investment risk operations engine Clearwater Analytics(NYSE: CWAN), the most comprehensive technology platform for investment management, today announced breakthrough embedded agentic AI capabilities within Beacon by CWAN, its enterprise risk and quantitative analytics platform, enabling risk teams to accelerate model validation, exposure analysis, and decision-making. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260126906084/en/ As regulatory scrutiny intensifies and portfolio complexity reaches unprecedented levels, traditional risk platforms are failing institutional investors when they need answers most. Built specifically for quantitative developers and risk professionals managing complex institutional portfolios, CWAN’s embedded AI operates within Beacon’s calculation engine itself, training the agents our client
Seasoned European Software Executive David Coste to Join Battery Ventures27.1.2026 09:00:00 CET | Press release
Coste, a longtime leader at pan-European ERP provider Forterro, will be a Battery executive-in-residence Battery Ventures, the global, technology-focused investment firm, announced it has hired former Forterro executive David Coste as an executive-in-residence based in its London office, effective next month. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260127122321/en/ David Coste, a former Forterro executive who begins a new executive-in-residence role with global investment firm Battery Ventures in London in February. At Battery, Coste will work closely with Battery Partner Zak Ewen and General Partner Morad Elhafed, among others, to help source and evaluate business-technology investments throughout Europe. Battery first opened its London office in 2016 and, since 2005, has completed more than 150 transactions across 13 countries including the U.K., Germany, France, the Netherlands, Belgium, Switzerland, Sweden and Nor
Castles Technology Partners With Loomis Pay to Power European Expansion With Next-Generation Android Devices27.1.2026 08:00:00 CET | Press release
Cutting-edge Android payment and Point-of-Sales (POS) technology set to transform the European payments and POS landscape Castles Technology, a global leader in Android payment acceptance devices, has been selected by Loomis Pay, the POS and digital payment division of Loomis, to support its European expansion. Through this collaboration, Loomis Pay will strengthen its capacity to deliver flexible and secure POS and payment solutions tailored to merchant preferences. As well as empowering merchants and their customers to transact the way they prefer, cash, card and digital. Following an extensive market review, Loomis Pay chose Castles Technology for its leadership in Android-based payment solutions, recognized for versatility, reliability, and innovation across its latest Android devices. Loomis Pay will deploy their POS and payment services on the portable S1F4 Pro, the PINPAD S1P2 and the unattended S1U2M4, as well its CasHUB TMS and Marketplace. Castles Technology and Loomis Pay ha
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom