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
Insurance Investment Outsourcing Surpasses $5.5 Trillion as Private Markets and Global Expansion Reshape the Industry20.5.2026 09:00:00 CEST | Press release
IIOR Shows Record Outsourced Insurance AUM, Private Assets Near $1 Trillion, and Europe Emerging as a Global Growth Engine Clearwater Analytics (NYSE: CWAN) today released the 2026 Insurance Investment Outsourcing Report (IIOR), produced in partnership with DCS Financial Consulting. The report captures $5.5 trillion in third-party general account insurance assets under management across 96 asset managers, a 23% increase year-over-year and a 65% increase since 2021, alongside $1.8 trillion in assets under advisement across 12 investment consultants. The findings point to an outsourcing market that has become larger, more global, and materially more complex. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520780028/en/ The 2026 IIOR reveals defining trends reshaping insurance investment management: Private Markets Cross a Threshold. Third-party private insurance AUM has more than doubled since 2021, reaching $947 billion and
Factbird Adds Quality & Compliance and Reports to its Manufacturing Intelligence Platform20.5.2026 08:00:00 CEST | Press release
Two new capabilities give multi-site manufacturers standardized workflows, traceable records, and automated reporting across every plant. Today, Factbird is announcing two major additions to its manufacturing intelligence platform: Quality & Compliance and Factbird Reports. Both address a problem that compounds as manufacturers grow. More sites mean more variation in how work gets done. More regulation means more documentation pressure on frontline teams. And more data, when fragmented across systems, often slows decisions rather than speeding them up. Solving this has traditionally meant large IT projects and months of deployment. “Enterprise manufacturers shouldn’t have to choose between capability and simplicity,” said Mogens Arne Hansen, Chief Technology and Product Officerat Factbird. “With Quality & Compliance and Reports, you can have standardized, audit-ready operations and automated performance reporting across every site, deployed in days, used by the people on the floor.” Qu
The LYCRA Company to Successfully Complete Comprehensive Financial Restructuring20.5.2026 04:23:00 CEST | Press release
Company positioned for long-term growth, operational excellence, and continued customer-focused innovationWill emerge from financial restructuring with enhanced financial flexibility and significantly less debtNew ownership and Board of Directors committed to executing on vision to take the business to the next levelBruce Rubin appointed Executive Chairman and Dean Williams appointed Interim Chief Executive Officer The LYCRA Company, LLC (“the Company”), a global leader in developing fiber and technology solutions for the apparel and personal care industries, will successfully complete its comprehensive financial restructuring process and emerge from Chapter 11 protection on May 20, 2026. The LYCRA Company has established a durable capital structure that will enable the Company’s pursuit of its growth strategy through investment in innovation, customer partnerships, and global operations. The Company will emerge from its comprehensive restructuring process with significantly enhanced f
Johns Manville Announces John Vasuta as New CEO19.5.2026 22:30:00 CEST | Press release
Johns Manville (JM), a global building and specialty products manufacturer and a Berkshire Hathaway company, announced today that Bob Wamboldt will retire and John Vasuta will assume the role of President and Chief Executive Officer, effective August 1, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260519630814/en/ John Vasuta will become JM's CEO and President on August 1, 2026. Vasuta joined Johns Manville in 2019 as President of the company’s Engineered Products business. He also serves on the Board of Directors for EJ, a global leader and private manufacturer of infrastructure access products for water, sewer, utilities, drainage and telecommunications. “It’s an extraordinary privilege to step into the role of CEO,” Vasuta said. “I’m deeply honored to continue serving our customers and supporting the employees whose dedication makes our success possible.” Before joining JM, John held leadership roles at Bridgeston
Mereo Insurance Announces Move into Excess Casualty Insurance19.5.2026 22:12:00 CEST | Press release
Mereo expands into Excess Casualty Insurance by acquiring renewal rights to Everen Specialty Ltd.’s Excess Casualty Energy portfolio. Mereo Insurance Limited (“Mereo”) today announced a renewal rights transaction with Everen Specialty Ltd. (“ESL”), a member of the Everen Group, for ESL’s Excess Casualty Energy portfolio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260519154915/en/ David Croom-Johnson, President & Chief Executive Officer of Mereo Insurance Limited Under the transaction, Mereo will become the insurance carrier on a go-forward basis for both new and renewed business effective June 1, 2026. ESL’s underwriting team and underwriting systems supporting the Excess Casualty Energy portfolio will also transition to Mereo, led by former ESL Chief Underwriting Officer, Carla Greaves. Under the terms of the agreement, Mereo will provide ESL insureds with continuity of coverage, access to AM Best “A- rated” paper, and
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