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
BeOne Medicines’ BEQALZI™ (sonrotoclax) Approved by U.S. FDA as First and Only BCL2 Inhibitor for R/R Mantle Cell Lymphoma13.5.2026 19:27:00 CEST | Press release
BEQALZI is a foundational BCL2 inhibitor designed for greater potency and selectivity, with potential to improve efficacy, tolerability, and convenience versus others in the classApproval of BEQALZI marks the first new BCL2 inhibitor approved in a decade in the U.S. and the only BCL2 inhibitor approved in MCL, aiming to set a new standard of innovation BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BEQALZI™(bee-KAHL-zee; sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. BEQALZI was designed to enhance BCL2 inhibition—with greater potency, selectivity, and a pharmacologic profile with potential to improve efficacy, tolerability, a
Boomi Unveils Innovations That Power the Agentic Enterprise13.5.2026 16:30:00 CEST | Press release
Orchestration capabilities simplify workflows, while advanced agent connectivity and an enhanced context layer activate data and scale AI Boomi, the data activation company for AI, today announced a major expansion of the Boomi Enterprise Platform at Boomi World 2026, introducing new capabilities across orchestrated agentic workflows, agentic engineering, governed agent connectivity, grounded agent context, and localized agent infrastructure. Together, these innovations are designed to power the agentic enterprise — where agents and humans work together to drive action and operationalize AI at scale. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513996223/en/ Boomi Unveils Innovations That Power the Agentic Enterprise The enterprise has reached a defining moment as AI becomes the primary interface for work and MCP emerges as the new standard. While the shift toward a headless, agentic enterprise is inevitable, this visio
Boomi and Red Hat Collaborate on Production-Ready Agentic AI13.5.2026 16:30:00 CEST | Press release
Companies team to deliver a unified, enterprise-scale agentic stack to help organizations with managing data sovereignty and optimizing AI costs Boomi, the data activation company for AI, and Red Hat, the world’s leading provider of open source solutions, today announced a strategic collaboration to deliver a single, integrated stack for deploying agentic AI at scale. For many organizations, building production AI today means assembling numerous disconnected vendor choices spanning agent builders, orchestration tools, governance platforms, model providers, integration middleware, and security infrastructure, which can lead to data leaks and unpredictable costs. Boomi and Red Hat are working together to simplify AI innovation for customers by bringing together Boomi’s Agentstudio with the enterprise-grade power of Red Hat AI. This makes it easier for organizations to build agents that solve real business problems while supporting corporate standards for sovereignty, infrastructure flexi
Boomi and Couchbase Partner to Power Enterprise AI Agents with Trusted Recollection, Connectivity, and Governance13.5.2026 16:30:00 CEST | Press release
Partnership enables customers to accelerate AI agents from pilot to production with accuracy, performance, and control by combining Boomi's connectivity, agent runtime, and governance with Couchbase's operational data platform Boomi, the data activation company for AI, and Couchbase, Inc., the operational data platform for AI, today announced a partnership through which the two companies are collaborating closely to accelerate AI pilots to production. The companies will co-engineer solutions that give customers a production-ready foundation for agentic AI, combining Boomi's connectivity, runtime, and governance for AI agents with Couchbase's scalable recollection and vector capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513350337/en/ Enterprises deploying AI agents today face a common challenge: while agents perform well in pilots, they struggle to scale due to inconsistent access to trusted context, recolle
Lenovo Named a Leader and Star Performer in Mid-Market Digital Workplace Solutions Assessment by Everest Group13.5.2026 15:00:00 CEST | Press release
One of only two Star Performers, Lenovo was recognized for helping mid-market CIOs with cost reduction, faster onboarding, productivity gains Lenovo’s ability to help mid‑market organizations reduce IT support costs, accelerate time-to-value, and improve workforce productivity at scale has earned recognition as a Leader and Star Performer in Everest Group’s 2026 Digital Workplace Services PEAK Matrix® Assessment for Mid‑Market Enterprises. Lenovo’s Digital Workplace Solutions (DWS) enable customers to improve speed, cut costs, and elevate employee experiences, helping new employees reach productivity up to 50% faster, increasing employee satisfaction by 30%, lowering end-user support costs by up to 30%, and proactively resolving up to 40% of issues to minimize downtime and business disruption1. Lenovo delivers these results by uniquely integrating device, services, and intelligence into a single, scalable delivery model built for the mid‑market. Through lifecycle services delivered at
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