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
Honoring the World’s Most Exceptional Tourism Destinations: Nominations Now Open for the Second TOURISE Awards2.9.2026 15:55:00 CEST | Press release
The TOURISE Awards showcase the globe's most influential destinations, highlighting the richness of culture, the power of human connection, and groundbreaking advancements in travel. Six categories are open for nominations, including a new award for Best Wellness Destination, plus a flagship Best Overall Destination award selected by the jury. Winners will be honored at the TOURISE Awards ceremony, held in conjunction with the TOURISE Summit in Riyadh, March 23-25, 2027. The second cycle of the TOURISE Awards officially launched today as a continuing global benchmark celebrating premier tourism destinations. The TOURISE Awards set a new global benchmark in 2025, celebrating destinations that deliver distinctive, purpose-driven travel experiences. In 2027, TOURISE will celebrate the destinations shaping tomorrow’s tourism; that deliver value across the entire journey, align with traveler purpose, and set new global standards for how the world travels, connects, and grows. Nominations ar
ABB Extends Engagement with Wipro to Deliver and Enhance Global Digital Workplace Services2.9.2026 15:30:00 CEST | Press release
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading AI-powered technology services and consulting company, has renewed its long-standing Digital Workplace Services contract with ABB, a global technology leader in electrification and automation. Building on an established relationship spanning multiple years, Wipro will continue delivering end-to-end AI-enabled Digital Workplace Services for ABB's global operations while further enhancing employee experience through advanced automation, AI-powered service capabilities, and workplace modernization initiatives. Powered by Wipro Intelligence™, the unified suite of AI platforms, solutions and transformative offerings, this engagement will modernize ABB’s digital workplace with AI-led, experience-centric capabilities delivered through Wipro’s AI Live Workspace™ and Digital Workplace Services offerings and operationalized through WINGS, Wipro’s AI-powered delivery platform for operations. Through SmartOps, Wipro’s AIOps capability,
Egon Zehnder Names Ayşe Güçlü Onur Global Human Resources Practice Leader2.9.2026 15:00:00 CEST | Press release
Egon Zehnder has appointed Ayşe Güçlü Onur as Global Leader of its Human Resources Practice. This appointment comes as companies and boards increasingly look to CHROs to help shape business strategy, lead transformation, build leadership pipelines, and navigate major shifts in culture and the workforce. "CHROs used to be evaluated by how well they supported the business. Today, the best drive it," said Onur. "Our role is to help CHROs move from a seat at the table to a hand in business growth. We help them connect leadership decisions, talent, and culture directly to elevated performance. That's the shift Egon Zehnder is built to guide with our leadership advisory services." Egon Zehnder’s Human Resources Practice partners with companies to discover, develop, and transform future-ready CHROs, helping them shape the future of the function. This includes executive search, leadership assessment and development, board effectiveness, culture, succession planning, organizational transformati
Safe Software to Increase Global Headcount by Over 15% as Demand for AI-Ready Data Grows2.9.2026 15:00:00 CEST | Press release
The FME creator is recruiting for more than 60 roles across the UK, US and Canada before the end of December, less than a year after crossing $100M in revenue Safe Software, the creator of FME, the only All-Data, Any-AI enterprise integration platform with true support for spatial data, today announced it is recruiting for more than 60 roles throughout the remainder of 2026. The hiring will take the company past 400 employees, increasing headcount by over 15%, with new positions across the United Kingdom, the United States and Canada. The expansion follows a year in which Safe crossed $100 million in annual revenue, growing close to 20 percent year over year and moving ahead of schedule on its target of $250 million by 2028. The company also grew its employee base by over 20% in the same period. "The incredible growth that we’ve seen over the last 30+ years at Safe has always been a testament to the great people behind what we do," said Don Murray, Co-Founder and CEO of Safe Software.
Owkin to License K Pro AI Scientist and Multimodal Oncology and Immunology Datato Boehringer Ingelheim2.9.2026 14:00:00 CEST | Press release
Owkin, the agentic AI company striving to transform drug discovery and development for biopharma, today announced a license agreement with Boehringer Ingelheim for K Pro, Owkin’s AI Scientist, together with multimodal patient data, aiming to speed up the discovery process across multiple indications in oncology and immunology. This agreement builds upon an initial pilot undertaken by Owkin with Boehringer in 2025. In that pilot Owkin delivered deep spatial insights into the tumor microenvironment of a gene target through its MOSAIC dataset. Under the new agreement, Owkin will license multimodal oncology data to Boehringer and will generate new multimodal data in immunology. Owkin licenses, sources and generates multimodal patient data in collaboration with its global patient data network. Boehringer Ingelheim’s teams will access and analyze this data through K Pro, which provides a single environment to interrogate data and run reproducible analyses. K Pro’s reasoning capabilities supp
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