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
Venture Global and ConocoPhillips Announce 20-Year LNG Sales and Purchase Agreement1.10.2026 22:30:00 CEST | Press release
Today, Venture Global, Inc. (NYSE: VG) and ConocoPhillips (NYSE: COP) announced a new, long-term Sales and Purchase Agreement (SPA) for liquefied natural gas (LNG). Under the SPA, ConocoPhillips will buy 1.0 million tonnes per annum (MTPA) of LNG from Venture Global for 20 years, starting in 2030. "Venture Global is proud to welcome ConocoPhillips, one of the world's leading energy companies, as a long-term partner," said Venture Global CEO Mike Sabel. "This agreement reflects continued market confidence in our proven ability to deliver reliable, low-cost U.S. LNG quickly and at scale. We look forward to supporting ConocoPhillips' growing global LNG portfolio for decades to come." About Venture Global Venture Global is an American producer and exporter of low-cost U.S. liquefied natural gas (LNG) with over 100 MTPA of capacity in production, construction, or development. Venture Global began producing LNG from its first facility in 2022 and is now one of the largest LNG exporters in th
UL Solutions Inc. Completes Acquisition of Eurofins Scientific’s Electrical & Electronics Business1.10.2026 22:05:00 CEST | Press release
UL Solutions Inc. (NYSE: ULS), a global leader in applied safety science, today announced it has completed the acquisition of the electrical and electronics (E&E) business of Eurofins Scientific SE. “This acquisition extends our 132-year commitment to our mission of working for a safer world,” said President and CEO Jennifer Scanlon. “We are thrilled to welcome our new colleagues to UL Solutions. By bringing together complementary expertise and capabilities, we are expanding our global footprint, enhancing our TIC services for electrical safety and connected products, and adding services that support customers around the world.” Eurofins’ E&E business provides testing, compliance and certification services that support global market access for electromagnetic compatibility and wireless testing, electrical safety, medical devices and other technologies. The acquisition adds laboratories and accreditations in EMEA, Asia and the United States to UL Solutions’ global network. About UL Solu
Barnes Aerospace Acquires ATL Turbine Services, Establishing First Aeroengine Component Repair Operation in Europe1.10.2026 20:50:00 CEST | Press release
ATL Turbine Services strengthens Barnes Aerospace's global repair network with specialized turbine component repair capabilities that will serve as a platform for growth across the region. Barnes Aerospace, a global provider of component engineering, manufacturing and repair solutions for the aerospace industry, today announced the acquisition of ATL Turbine Services Ltd. ("ATL Turbine Services"), a Dundee, Scotland-based specialist in the refurbishment and repair of hot-section gas turbine components, marking Barnes Aerospace's first dedicated component repair and overhaul presence in Europe. The acquisition establishes Barnes Aerospace's initial Component Repair and Overhaul (CRO) footprint in Europe, expanding the company's aftermarket presence and strengthening its ability to serve customers in the region. ATL Turbine Services brings established in-region repair, assessment, coating, and engineering capabilities that complement Barnes Aerospace's existing global repair network and
Netmore Named Smart Company of the Year at the Premios iAgua 20261.10.2026 19:00:00 CEST | Press release
Netmore recognized for commitment to Spanish water market backed by locally developed products, proven smart metering expertise, and deep local market knowledge Netmore Group, the leading network operator and platform provider for Massive IoT, today announced it has been named Empresa Smart del Año — Smart Company of the Year — at the Premios iAgua 2026, the awards of iAgua, the Spanish-speaking water sector's leading media platform. The award was presented at the closing gala of the Spain Smart Water Summit, held at the Meliá Avenida América in Madrid. The award recognises a company that has taken an unusual route into water. Netmore is not a technology firm that added connectivity to its portfolio: it is a network operator that decided to specialise in the water cycle. In eighteen months, it has completed four acquisitions and become the world's largest LoRaWAN® network operator, with more than eighteen million IoT devices under contract across more than fifty countries. Its commitme
Elliptic Sets the Engineering Bar for On-Chain Risk With “Built for Compliance” Paper as New Rules Take Hold and Banks Launch a Joint Stablecoin1.10.2026 15:40:00 CEST | Press release
Built for compliance arrives as crypto compliance rules tighten worldwide and a bank-led stablecoin enters the market Elliptic, the global leader in on-chain risk management, today published Built for compliance, a paper setting out the nine engineering decisions that determine whether an on-chain risk system can support fast, accurate and defensible compliance decisions at agentic scale. Machines are already moving money on their own, at machine speed. Compliance teams now have to make hundreds of thousands of decisions a day, at that same speed. However, many on-chain risk systems were never engineered to support that pace. A compliance system that computes exposure on a schedule delivers stale results. One that defines blockchain coverage loosely enough lets a screening miss exposure entirely. A system that skips testing disaster recovery, a spike or an outage, takes down the customer’s compliance system too. That gap between machine speed and system design is exactly what regulator
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