SAMSUNG-BIOEPIS
10.9.2019 14:02:09 CEST | Business Wire | Press release
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
83% of Restaurants Are Invisible in AI Search: New Uberall Report Reveals the Discovery Gap Reshaping the Quick Service Restaurant Industry7.5.2026 19:35:00 CEST | Press release
Industry-first benchmark study analyzes how ChatGPT, Gemini, Perplexity, Copilot and Google AI Overviews recommend restaurants Uberall, the global leader in location marketing technology, today released Fast Food, Faster Discovery: The 2026 GEO Playbook for Multi-Location QSRs — the industry’s first benchmark report measuring how AI assistants recommend restaurants and how multi-location QSR (Quick-Service Restaurant) brands can adapt their local marketing strategies for AI-mediated search. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507962493/en/ Fast Food, Faster Discovery: Why AI Is the New Drive-Thru The report draws on Uberall’s proprietary GEO Studio benchmark data and aggregated performance metrics from its global QSR customer base. Its central finding: as consumer restaurant discovery rapidly shifts from traditional search to AI assistants, the majority of QSR locations are effectively absent from AI-generated
Department of Health - Abu Dhabi and ŌURA Partner to Advance Preventive Health in Abu Dhabi7.5.2026 18:57:00 CEST | Press release
Initially focused on women’s health, the partnership will unite Department of Health - Abu Dhabi’s longitudinal health data with ŌURA’s real-time insights, underpinned by a rigorous joint data governance framework Department of Health—Abu Dhabi (DoH) and ŌURA, maker of the world’s leading smart ring, Oura Ring, today announced a joint research programme to study how continuous wearable data can advance preventive health. The collaboration marks the beginning of a long-term partnership to advance Abu Dhabi’s prevention-first, data-driven healthcare agenda, and will initially focus on women’s health and cardiometabolic risk. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507073495/en/ HE Mansoor Al Mansoori (Left) and Tom Hale (Right) The collaboration builds on Abu Dhabi’s advanced public health infrastructure and longitudinal health data assets, integrating them with ŌURA’s real-time, continuous insights across key health
Rave Sues Apple in Five Countries Over App Store Removal7.5.2026 17:03:00 CEST | Press release
Alleges Antitrust Violations in U.S., Canada, Brazil, the Netherlands and Russia to Restore Access for Users and Defend Fair Competition for App DevelopersAlleges Apple Acted to Stop Rave from Competing with Apple’s Own Co-Viewing AppRave Launches Proprietary, AI-enabled Moderation System, a-eye.com, to Protect Users from Explicit Content Rave Inc. (“Rave” or the “Company”), the developer and operator of the Rave app, a cross-platform co-viewing “super app” with more than 225 million downloads, today announced that it has filed antitrust lawsuits against Apple in five countries: the United States, Canada, Brazil, the Netherlands and Russia. The lawsuits challenge Apple’s unilateral and anticompetitive decision to remove Rave from its App Store, thereby distorting competition, reducing consumer choice in co-viewing functionalities and increasing the costs to users of switching between iPhone and competing smartphone devices. Rave operates a social entertainment app that allows users in
emnify named a Visionary in the 2026 Gartner® Magic Quadrant™ for Managed IoT Connectivity Services, Worldwide7.5.2026 17:00:00 CEST | Press release
First-time positioned vendor emnify recognized for its Completeness of Vision and Ability to Execute emnify, a global provider of cloud-native IoT connectivity solutions, today announced it has been recognized as a Visionary in the 2026 Gartner® Magic Quadrant™ for Managed IoT Connectivity Services, Worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507642325/en/ emnify named a Visionary in the 2026 Gartner® Magic Quadrant™ for Managed IoT Connectivity Services, Worldwide. Get the report As a first-time recognized vendor, emnify believes this recognition reflects its forward-looking approach to IoT connectivity, building a platform designed to anticipate where enterprise needs are heading rather than replicating the connectivity models of the past. "We feel being named a Visionary in our first appearance in the Gartner® Magic Quadrant™ recognizes our deliberate strategy of the last decade: from owning our core netw
UAE Commits $49bn to Local Manufacturers7.5.2026 16:00:00 CEST | Press release
UAE to localize 5,000+ products in push for industrial sovereignty – Minister of Industry and Advanced Technology and ADNOC Group CEO Dr. Sultan Al Jaber The United Arab Emirates (UAE) pledged $49 billion in industrial procurement opportunities on Monday and announced plans to localize more than 5,000 products as the Gulf state doubled down on its industrial sovereignty agenda. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507855698/en/ UAE commits $49bn to local manufacturers (Photo: AETOSWire) Dr. Sultan Al Jaber, UAE Minister of Industry and Advanced Technology, made the announcement at the opening of the fifth edition of Make it in the Emirates, which follows a period that has tested the region. “History remembers the challenges nations face. But it also remembers how nations respond to them and what they build next,” he said. TA’ZIZ announced $40.5 billion worth of agreements aimed at expanding UAE chemical producti
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