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
Takeda Employees Select Four New Global Corporate Social Responsibility Collaborations to Advance Climate-Resilient Health Systems18.9.2026 07:00:00 CEST | Press release
2026 Awardees are Corus International,Humanity & Inclusion Handicap International, Kwame Nkrumah University of Science and Technology (KNUST) and Terre des hommes Foundation (Tdh)Commitment of USD 22.2 Million Increases Takeda’s Total Global CSR Program Contributions to USD 260.9 Million Across 42 Diverse Collaborations Worldwide, With 20 Currently Ongoing in 42 Countries Takeda (TSE:4502/NYSE: TAK) announced that it has awarded a total of USD 22.2 million to four new Global Corporate Social Responsibility (CSR) partners as part of the company’s ongoing commitment to supporting climate-resilient health systems in low- and middle-income countries around the world and aligned with the company’s purpose of better health for people, brighter future for the world. As climate change, extreme weather events and shifting global aid priorities continue to challenge healthcare access, Takeda is advancing its 2026 collaborations with the goal of expanding equitable access, strengthening health sy
Beacon Acquires Haize Labs to Power AI for the Real Economy17.9.2026 16:30:00 CEST | Press release
Haize Labs leadership will anchor Beacon’s new applied AI research group, accelerating the deployment of AI across the essential businesses Beacon owns Beacon Software (Beacon), the first centralized AI holding company, today announced that it has acquired Haize Labs, an AI reliability company that tests and safeguards AI agents for real-world deployment. The Haize Labs team will join Beacon to form its Applied AI Research Group, with co-founder and CEO Leonard Tang joining as VP of AI Research to lead the AI operating system that is deployed across Beacon’s companies. Beacon believes that the fastest way to bring AI to the traditional economy is through the software businesses that essential industries already use and trust, equipping them with AI infrastructure. Beacon acquires these businesses for long-term growth and connects them to a centralized AI operating system that compounds with each additional acquisition and industry. The addition of the Haize Labs team will strengthen th
TIMELAB Develops OEM/ODM Hair Straightener Reaching 200°C at All Three Measured Points in 15 Seconds17.9.2026 16:00:00 CEST | Press release
Testing at 230 V with a 260°C setting confirmed at least 200°C after 15 seconds at all three measured plate locations (front, center and rear), not just a single point. TIMELAB Co., Ltd., a Japanese beauty-appliance OEM/ODM provider, has developed a hair straightener for OEM/ODM customization for international hair care brands and professional markets. In testing at 230 V with a 260°C setting, all three measured plate locations reached at least 200°C after 15 seconds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914187865/en/ Three-Point Plate Testing A European-market development unit with a maximum setting of 260°C was tested at 230 V. Fifteen seconds after power-on, readings at the front, center and rear were 212.5°C, 227.5°C and 200.0°C, respectively. From around 60 seconds onward, temperature differences among the three points narrowed, indicating a stable trend. Precision Temperature Control An NTC sensor inside t
Earnix Brings Agentic AI to the Decisions That Drive Insurance Performance17.9.2026 15:09:00 CEST | Press release
Agent Hub, part of Earnix AIOS, brings more than 25, insurance-specific agents and apps into Earnix’s governed pricing, underwriting, and customer decision solutions- improving workflows and business performance Earnix today announced the introduction of Agent Hub, a curated catalog of insurance-specific AI agents and apps within Earnix AIOS — the AI Orchestration System powering Earnix’s pricing and rating, underwriting, and customer engagement solutions. Agent Hub brings agentic AI directly into these solutions, enabling more intelligent workflows and strengthening the high-stakes decisions that shape pricing, underwriting, customer engagement, growth, and profitability. In an increasingly turbulent insurance environment, the useful life of an insurance decision is getting shorter. Risk and market conditions are changing faster, making growth, profitability, and portfolio performance harder to manage. AI is increasing the speed and scope of what insurers can analyze, recommend, and i
Medisca Launches Global Peptide Division17.9.2026 15:07:00 CEST | Press release
New division brings API-grade peptides and Medisca’s quality-first pharmaceutical expertise to a rapidly evolving area of personalized medicine Medisca today announced the launch of Medisca Peptides, a dedicated global division focused on expanding access to API-grade peptides and building an integrated peptide platform for pharmaceutical and personalized medicine markets worldwide. As the peptide landscape evolves, Medisca is proactively building the capabilities and infrastructure needed to support API-grade peptides within applicable regulatory frameworks. The launch represents a significant long-term commitment to peptides, including the expansion of Medisca’s portfolio, strategic manufacturing relationships, and the pharmaceutical infrastructure needed to support the category’s growth. It also signals Medisca’s ambition to become a leading force in the next generation of peptide innovation. For Medisca, the opportunity is familiar. More than 35 years ago, the company was founded t
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