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
Brightfin Launches Spend Clearly AI to Help Enterprise Tech Leaders Take Control of Growing IT and AI Costs6.5.2026 22:32:00 CEST | Press release
New AI-powered optimization app delivers real-time visibility, cost reduction, and predictive forecasting as enterprise AI spending accelerates Brightfin, a leader in AI native IT cost optimization, today announced the launch of Spend Clearly AI, an intelligent optimization app purpose-built for enterprise technology leaders navigating the dual pressures of rising IT complexity and rapidly escalating AI investment. As organizations race to deploy AI apps, models, and infrastructure, technology demands on the budget are expanding faster than ever and growing harder to track, justify, and control. The modern enterprise IT bill has become a moving target. Spend Clearly AI gives CIOs, CTOs, and IT finance teams a single, intelligent app to see exactly where every technology dollar is going, eliminate waste, and stay ahead of costs before they spiral. "Stop thinking about IT as a cost problem. The goal isn't just to spend less — the goal is to spend better," said Joel Martins, CEO of Bright
iQmetrix to Showcase Intelligent Commerce Operating System and Catalyst Innovation at DTW Ignite 20266.5.2026 19:20:00 CEST | Press release
Bronze sponsor debut includes Catalyst project innovation, live platform demo, and a unified AI‑native commerce vision iQmetrix, the Intelligent Commerce Operating System for telecom, announced today it will exhibit, speak, and compete as a bronze sponsor at DTW Ignite 2026 in Copenhagen from June 23–25. The company will deliver a live product demo in The Loft, showcase its ODA PRISM Catalyst project alongside a consortium of global operators and technology partners, and exhibit at Booth #317 throughout the event. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260506948390/en/ The debut marks a milestone in iQmetrix’s global growth strategy and deepens its partnership with TM Forum, following its recent recognition as an ODA Component Directory Partner. The Future of Commerce Is Won at the Orchestration Layer DTW Ignite 2026’s theme, “The Future. Faster.,” captures the urgency facing communications service providers worldwid
Go Beyond the Guidebook: Why Ireland Rewards Those Who Slow Down6.5.2026 18:15:00 CEST | Press release
In a world where travel often feels rushed and driven by checklists, Ireland stands apart. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260501313521/en/ Lusty Beg Island Kesh, Co. Fermanagh The destination offers something deeper, drawing visitors beyond the expected toward richer encounters with its landscapes, culture and communities. As a compact island, Ireland gives holiday makers the chance to take in much of the destination while still travelling at a relaxed, unhurried pace. It’s a chance to slow down, not to do less, but to feel more - more calm, more connection, and more of what makes travel meaningful. This approach to travel is matched by Ireland’s natural warmth and welcome, helping visitors feel at home from the moment they arrive. Take the scenic route From the rugged coastline of the Wild Atlantic Way, one of the world’s longest coastal routes, to the rolling landscapes of Ireland’s Hidden Heartlands, Irela
TACTICA AI Introduces Region’s First AI Platform for Mission-Critical, Real-Time Operational Decisions6.5.2026 17:18:00 CEST | Press release
Built on deep tech developed by TII, TACTICA AI moves beyond dashboards to help decision-makers turn fragmented intelligence, sensor, and operational data into action Showcased during Make it in the Emirates 2026, the platform has already been validated through real-world deployments in mission-critical environments Built in Abu Dhabi, connected globally, TACTICA AI integrates partnerships with French-based Safran and Polish-based Satim TACTICA AI, an Abu Dhabi-based start-up, today introduced its multi-domain decision-support platform to a wider market during Make it in the Emirates 2026. At a time of increasing operational complexity and pressure to make faster, better-informed decisions, the platform is designed to transform fragmented intelligence, sensor, and operational data into real-time decisions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260506006177/en/ TACTICA AI Introduces Region’s First AI Platform for Mis
FlightSafety International Receives FAA Approval for Virtual Aircraft Preflight Inspection with Evaluation Mode6.5.2026 16:05:00 CEST | Press release
Three aircraft programs approved, with three more expected to receive approval in 2026 FlightSafety International Inc., the global leader in aviation training and simulation technology, today announced it has received Federal Aviation Administration (FAA) approval for Virtual Aircraft Preflight Inspection (VAPI) with Evaluation Mode for three aircraft training programs: the Embraer EMB-550, Gulfstream G500/G600, and Citation Latitude. This innovative capability allows pilots in initial training to complete a 3D virtual aircraft preflight inspection while in Training Mode, with the added ability to transition directly into the flight deck, followed by Evaluation Mode, that allows pilots to do their preflight check ride portion. “VAPI represents a meaningful advancement in training innovation,” said David Penney, VP of Safety, Courseware and Regulatory Affairs, FlightSafety International. “By leveraging an immersive 3D environment, it offers pilots a more engaging and practical way to de
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