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
Biocytogen Launches AI-Powered RenSuper™ Platform and Industry-First Fully Automated Antibody Discovery Infrastructure26.5.2026 14:00:00 CEST | Press release
Biocytogen today announced the launch of RenSuper Workstation, a next-generation AI-powered antibody discovery platform providing off-the-shelf access to a large-scale, experimentally validated library of fully human therapeutic antibody sequences, together with the RenSuper High-Throughput Antibody Manufacturing Automation Center, a fully automated infrastructure designed to accelerate antibody validation and production. Built on Biocytogen’s proprietary RenMice® platforms, RenSuper establishes a closed-loop antibody discovery engine combining in vivo immune repertoires, AI-driven candidate selection, automated experimental validation, and scalable manufacturing infrastructure. The platform supports the discovery and development of monoclonal antibodies, bispecifics, multispecifics, antibody-drug conjugates (ADCs), VHHs, and other advanced therapeutic modalities, significantly reducing the time and risk associated with antibody discovery. RenSuper Workstation: AI-Powered One-Click Tar
ViaLase Announces Global Commercial Introduction of the FLIGHT Procedure26.5.2026 14:00:00 CEST | Press release
First commercial femtosecond laser image-guided, high precision trabeculotomy (FLIGHT) treatments mark a new era in interventional glaucoma; one where precision, safety, and the patient experience define the new standard of care ViaLase, Inc., a commercial stage medical technology company pioneering incision-free, laser-based solutions for glaucoma, today announced the successful completion of the first commercial FLIGHT procedures performed at Centre for Sight in London by Sheraz Daya, MD, and Gus Gazzard, MD, and at Breyer, Kaymak & Klabe Augenchirurgie in Düsseldorf, Germany, by Karsten Klabe, MD. The first commercial FLIGHT procedures were performed using the ViaLuxe® Laser System to deliver an incision-free, image-guided femtosecond laser treatment designed to create precise channels through the trabecular meshwork to restore aqueous outflow and reduce intraocular pressure in patients with open-angle glaucoma. “Centre for Sight has always been committed to bringing meaningful inno
BioIVT to Spotlight ADME-Tox Expertise and Solutions at Summer 2026 Events26.5.2026 14:00:00 CEST | Press release
Company will demonstrate how high-quality, well-characterized biospecimens are critical to the success of both new approach methodologies (NAMs) and traditional studies BioIVT, the leading biospecimen solutions provider and global research partner for drug and diagnostic development, today announced it will showcase its broad portfolio of ADME-Tox solutions and research expertise at several leading industry events, including the 2026 MPS World Summit and the ISSX 16th European Meeting. The MPS World Summit takes place May 26-May 29, 2026, in Washington, D.C. BioIVT colleagues will be available at booth #115 to discuss research questions and needs, including preparation, handling, and utilization of the high-quality tissues and cells needed for microphysiological systems (MPS), as well as conducting ADME studies and bioanalysis. BioIVT offers an extensive range of control and disease state biospecimens, including SPHEROID CERTIFIED™ Hepatocytes as well as advanced HEPATOPAC® co-cultures
IHS Towers Publishes 2025 Sustainability Report26.5.2026 12:34:00 CEST | Press release
IHS Holding Limited (NYSE: IHS) (“IHS Towers”) group, one of the largest independent owners, operators, and developers of shared communications infrastructure in the world by tower count, has today published its 2025 Sustainability Report. The report covers sustainability activities from January 1, 2025 to December 31, 2025 and demonstrates IHS Towers’ continued commitment to its stakeholders, including, but not limited to, its employees, customers, suppliers, local communities, regulators, governments and shareholders. IHS Towers’ vision is to help create a connected world, where mobile connectivity promotes continued economic growth and social development. The communications infrastructure it provides is vital to enabling that connectivity. In 2025, IHS Towers continued to advance its four-pillar sustainability strategy – focusing on ethics and governance, environment and climate change, education and economic growth, our people and communities – as detailed in this report. Sam Darwi
Compass Pathways to Participate in Jefferies Global Healthcare Conference on June 3, 202626.5.2026 12:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will attend the Jefferies Global Healthcare Conference on June 3, 2026 and will participate in a fireside chat at 12:45pm ET. A live audio webcast of this event will be accessible from the “Events” page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational CO
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