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
Inspirit Capital Completes Acquisition of Kaplan Languages Group1.5.2026 01:17:00 CEST | Press release
Inspirit Capital, a specialist investor in corporate carve-outs, and Kaplan, the global education company, have announced the completion of Inspirit’s acquisition of Kaplan Languages Group (KLG) from Kaplan. Financial terms are not being disclosed. KLG, a leading global language education platform, comprises Kaplan International Languages, Alpadia Language Schools, Azurlingua, and ESL Education. Inspirit Capital will support KLG in delivering on its ambitious growth plans, whilst continuing its fundamental mission to transform lives through language education. The next phase of ownership will see the development and launch of a refreshed standalone brand identity for KLG, with further announcements to follow on this in due course. KLG will continue to use the Kaplan name under a transitional license from Kaplan, Inc. until a new brand is announced. About Kaplan Languages Group Since 2006, KLG has provided the highest quality language education and cultural immersion experiences. Kaplan
Grindr Nominates Three New Directors to Its Board of Directors30.4.2026 23:16:00 CEST | Press release
Grindr Inc. (NYSE: GRND), the Global Gayborhood in Your Pocket™, today announced the nomination of Rob Solomon, Lisa Gersh, and Fadi Hanna to stand for election to its Board of Directors at the Annual Meeting of Shareholders on June 2, 2026. Rob Solomon is a deeply seasoned technology CEO and operator in consumer internet and marketplaces. He has held CEO and COO roles at scaled platforms including GoFundMe, Groupon, and Kayak-predecessor SideStep, and is currently CEO of leading electric aviation company H55. Lisa Gersh is a CEO and long-tenured public company director with deep experience across consumer brands, media, and commerce. She has served on the Hasbro (NASDAQ: HAS) board since 2010 and has led businesses including Oxygen Media, GOOP, and Alexander Wang. Fadi Hanna is Chief Risk Officer at Bloomberg L.P., overseeing enterprise risk across the organization. He previously worked at J.P. Morgan and has served on the board of Immigration Equality. “Over the last few years, we bu
The Empire State Building Celebrates 95 Years as the ‘World’s Most Famous Building’30.4.2026 22:42:00 CEST | Press release
New Tickets, Exclusive Offers, and Special Anniversary Programs Kick off May 1 The Empire State Building (ESB), the “World’s Most Famous Building,” will celebrate its 95th anniversary on May 1, 2026, with new offers at the Empire State Building Observation Deck, a special birthday tower lighting display, and a slate of celebrations to honor its legacy and future. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260430693323/en/ The Empire State Building Celebrates 95 Years as the ‘World’s Most Famous Building’ “The Empire State Building celebrates its 95th anniversary, still the ‘World’s Most Famous Building,’ a modernized, sustainability leader as technologically advanced today as the day she was completed, and the winner of #1 Top Attraction in the United States in Tripadvisor’s Travelers’ Choice Awards for 2026,” said Anthony E. Malkin, chairman and CEO of Empire State Realty Trust. Anniversary Offerings and Experiences To
MRM Health’s Lead Candidate MH002 Granted Fast Track Designation by U.S. FDA for the Treatment of Mild-to-Moderate Ulcerative Colitis30.4.2026 22:17:00 CEST | Press release
Recognizes the potential of MH002 to address a serious medical condition with high unmet need Enables accelerated development and increased FDA interactions to streamline review process MRM Health will be presenting at upcoming Digestive Disease Week (DDW) 2026, taking place from May 2nd – May 5th in Chicago, IL, USA MRM Health, a clinical-stage biopharmaceutical company developing therapeutics for immune-mediated diseases, which unlock the power of the microbiome to restore immune balance, today announced that MH002, the Company’s lead rationally designed Live Biotherapeutic Product (LBP) candidate, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of mild-to-moderate ulcerative colitis (UC). MH002 today is the most advanced LBP targeting inflammatory bowel disease (IBD)-specific mechanisms and is composed of a rationally designed microbial consortium of six well-characterized commensal strains. The FDA’s Fast Track is a process d
Rimini Street Announces Fiscal First Quarter 2026 Financial and Operating Results30.4.2026 22:01:00 CEST | Press release
First Quarter Financial Highlights Include: Remaining Performance Obligations (RPO) of $643.6 million, up 16.4% year over year Adjusted Calculated Billings of $92.2 million, up 22.9% year over year Adjusted Annualized Recurring Revenue (ARR) of $388.0 million, up 5.0% year over year Rimini Street, Inc., (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, managed services and Agentic AI ERP innovation solutions, and the leading third-party support provider for Oracle, SAP and VMware software, today announced results for the fiscal first quarter ended March 31, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260430598629/en/ Rimini Street Announces Fiscal First Quarter 2026 Financial and Operating Results “Our first quarter results reflect continued growth and accelerating momentum in our core Rimini Support™ business as organizations turn to the proven Rimini Smart Path™ to execute their global E
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