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
ATLAS Infrastructure Invests in H2O America, Backs Long-Term Growth Strategy10.3.2026 18:29:00 CET | Press release
ATLAS anchors H2O America’s equity raise and establishes new substantial shareholdingUpsized transaction highlights strong market support for H2O’s long-term strategy and sector leading growth outlookH2O’s organic growth fully equity funded into 20281 ATLAS Infrastructure (“ATLAS”) is a specialist Global Listed Infrastructure investor managing funds on behalf of long-term infrastructure clients. Following the recent equity placement, ATLAS’s actively managed accounts hold ~10.8% voting and economic interest in H2O America (“H2O”). ATLAS was pleased to support H2Os long‑term strategy to invest in local water and wastewater utility operations through our participation in the recent equity raise. ATLAS recognises the disciplined approach from H2O management which focuses on organic investment in existing businesses alongside targeted and accretive transactions such as the acquisition of Quadvest which materially expands H2O’s regulated water footprint in a premium high‑growth jurisdiction
TIXiMED Announces Promising Preclinical Data: Oral TIX100 Prevents Weight Regain After GLP-1 Cessation in Obesity Model10.3.2026 18:22:00 CET | Press release
TIX100 prevented weight regain in mice after semaglutide discontinuation Supports potential role as oral weight maintenance therapy following GLP-1 Receptor Agonist (GLP-1) treatment, addressing a major challenge in long-term obesity management TIXiMED, Inc., a clinical-stage pharmaceutical company developing a novel oral therapy targeting thioredoxin-interacting protein (TXNIP) for diabetes and metabolic disorders, is pleased to highlight new research by investigators at the University of Alabama at Birmingham (UAB) Comprehensive Diabetes Center. The study demonstrates that its oral compound, TIX100, effectively prevents weight rebound following discontinuation of GLP-1 treatment in a mouse model of diet-induced obesity. In the study, mice treated with semaglutide experienced significant weight loss of over 13% body weight during a 2-week treatment period while continuing a high-fat diet. Upon discontinuation of semaglutide, untreated mice rapidly regained 14% of their body weight, mi
Svante and Integrated Packaging Company Advance U.S. Biogenic CDR Project to Feasibility10.3.2026 14:57:00 CET | Press release
The bioenergy with carbon capture (BECCS) project aims to remove more than 500,000 tonnes per year of biogenic CO2 emissions from a U.S. paper mill’s recovery boiler Svante Development Inc. is co-investing to advance the project The project will generate high-quality carbon dioxide removal (CDR) credits to market to Voluntary Carbon Market (VCM) buyers. Svante Technologies Inc. (“Svante”) announced today that its bioenergy with carbon capture and storage (BECCS) project at a paper mill in the Southeast U.S. has progressed to the feasibility study phase. The project is being developed in partnership with an integrated sustainable packaging company, following an extensive screening and pre-feasibility study conducted across several of the partner’s mills. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310319382/en/ During the feasibility study phase, the companies will complete further engineering and design activities, cos
Forbes 40th Annual World’s Billionaires List10.3.2026 14:43:00 CET | Press release
Elon Musk Is World’s Richest Person Ever Recorded Forbes releases its 40th-annual World’s Billionaireslist, the definitive ranking of the planet’s richest people. Wealth surged to unprecedented levels over the past year, with fortunes climbing at a record pace. This year’s list features 3,428 billionaires, the most since the list’s inception in 1987. The world’s wealthiest people are worth a record $20.1 trillion combined, up from $16.1 trillion in 2025. Elon Musktops the Billionaires list for the second year in a row and is the richest person ever recorded, worth an estimated $839 billion. His net worth skyrocketed by half of a trillion dollars from last year, thanks to a rise in the value of Tesla, and SpaceX which is aiming to go public in 2026. Musk is the first person ever recorded to reach the $800 billion mark, as he moves toward becoming the world’s first trillionaire. “It’s the year of the billionaire,” said Chase Peterson-Withorn, Forbes Senior Editor, Wealth. “The planet add
Adtran sets intra-data center benchmark with all-new ultra-low-power LiteWave800™ LPO module10.3.2026 14:00:00 CET | Press release
News summary: AI clusters and GPU fabrics demand massive capacity, yet traditional 800G optics increase energy consumption, heat and cost burdens Adtran’s LiteWave800™ introduces a new class of ultra-low-power, low-latency DR8 LPO modules built on a fully re-engineered design Breakthrough energy efficiency of 1pJ/bit enables greener, scalable intra-data center links for next-generation AI and cloud workloads Adtran today launched LiteWave800™, an ultra‑low‑power 800Gbit/s DR8 linear pluggable optics (LPO) module engineered to help data centers address the power, latency, thermal and bandwidth demands of modern AI and machine-learning (ML) workloads. As GPU clusters grow and short-reach links scale across dense server racks, operators need 800Gbit/s optics that deliver higher capacity within strict power and cooling limits. LiteWave800™ answers this challenge with a fully re-engineered architecture that significantly reduces energy consumption. Operating at just 1pJ/bit and consuming on
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