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
Murata Develops World’s Smallest 008004-inch Size (0.25mm × 0.125mm) NTC Thermistor for Space-Constrained Temperature Sensing20.10.2026 04:00:00 CEST | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) announces the development of the world’s smallest* 008004-inch size (0.25mm × 0.125mm) NTC thermistor, the NCU01 series. Compared with Murata’s previous smallest 01005-inch size (0.4mm × 0.2mm) product, the new series reduces mounting area by approximately 60% while achieving equivalent temperature-sensing performance, with resistance tolerance of ±1% and B-constant tolerance of ±1%. Its ultra-compact size enables temperature sensing to be positioned in increasingly restricted spaces and closer to heat-generating components, supporting more accurate and responsive thermal monitoring in smartphones, wearable devices, and other densely integrated electronic devices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019189089/en/ [Murata Manufacturing Co., Ltd.] World’s smallest 008004-inch size (0.25mm × 0.125mm) NTC thermistor Murata plans to begin sample shipm
Hologic Signs Definitive Agreement to Acquire Reveal Genomics19.10.2026 21:30:00 CEST | Press release
Acquisition would expand Hologic’s oncology diagnostics portfolio to help inform treatment decisions for more women with breast cancer Hologic, a global leader in women’s health, today announced that it has signed a definitive agreement to acquire Reveal Genomics, a precision oncology company based in Barcelona, Spain, that develops advanced genomic diagnostic tests to help personalized cancer treatment, including its HER2DX test to help optimize therapy for patients with HER2-positive breast cancer. Breast cancer remains one of the most significant health challenges women face today. Reveal Genomics’ tests are highly complementary to Hologic’s existing oncology diagnostics, including the Breast Cancer Index® (BCI) test, the guideline-recognized genomic assay to help inform decisions regarding extended endocrine therapy in women with HR+ early-stage breast cancer. The combination of Hologic’s existing testing with Reveal Genomics’ portfolio represents a significant expansion of Hologic
An Active Role in Freshness: ProAmpac Introduces ProActive Intelligence Shelf Protect19.10.2026 21:27:00 CEST | Press release
ProAmpac, a global leader in flexible packaging and material science, introduces ProActive Intelligence™ Shelf Protect (SP) Series, giving food producers a new way to help preserve product quality and reduce costly spoilage. Designed for select meat, seafood, and dairy applications, the technology is FDA- and USDA-compliant for intended uses in fresh beef, fresh pork, cooked sausage, deli meat, fresh salmon, and fresh cheese. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019305953/en/ Clearshield®-SP Shrink Bag This direct food-contact biotechnology packaging helps reduce microbial growth associated with food spoilage in intended applications, supporting longer shelf life throughout storage and distribution. Shelf Protect’s patented biotechnology is built directly into food-contact packaging film. “For meat processors, every product lost represents an investment in production, packaging, and distribution that goes unreal
Vedanta Ltd Doubles Zinc Capacity in South Africa with US$ 600 Mn investment19.10.2026 19:19:00 CEST | Press release
Vedanta Limited doubled its annual zinc production capacity to 500,000 tonnes1in South Africa through an investment of nearly US$ 600 Mn at Gamsberg (Phase II) at Vedanta Zinc International (VZI). Gamsberg has one of the world’s most significant zinc deposits and is VZI’s flagship zinc mine. Inaugurated by South African President Cyril Ramaphosa and Vedanta Limited Director Priya Agarwal-Hebbar, this expansion marks one of the decade’s largest mining investments in South Africa. It advances Vedanta Limited’s position as the world’s largest2 zinc producer, with a vision of achieving 3 million tonnes of annual production across India and South Africa. Of this, 2 million tonnes are targeted from its subsidiary, Hindustan Zinc Limited the world’s largest integrated zinc producer, while Vedanta Zinc International business aims to contribute 1 million tonnes annually. This expansion strengthens the ZAR 21 Bn (nearly US$ 1.5 Bn) investment commitment Vedanta made at the 2018 South Africa Inve
Unlocking Digital Gold’s US$700bn Opportunity19.10.2026 18:00:00 CEST | Press release
The digital gold market, worth US$45–55bn today, could unlock up to US$700bn in latent demand, according to new research from World Gold Council and Boston Consulting Group. The report points to substantial untapped appetite among retail investors, with nearly nine in ten surveyed saying they would consider digital gold under the right conditions. The US$700bn opportunity represents the report’s estimate of total latent demand that could be released if today’s barriers to adoption were removed, rather than a near-term forecast. The report’s five-year base case sees digital gold growing by around 27% a year to US$160–170bn by 2031. That could rise to US$270–280bn over the same time if more barriers fall faster. Momentum is already building as financial markets undergo a broader digital transformation, bringing tokenised investment products increasingly into the mainstream. Tokenised gold, one segment of the digital gold market alongside vaulted digital gold, has grown fivefold in value
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