Samsung Bioepis Continues Global Expansion, Enters Brazilian Biopharmaceutical Market with BRENZYS™ (etanercept)
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.
Na Yun Kim
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Tigo’s Newest MLPE Addition – TS4-A-2F the Most Cost-Effective Rapid Shutdown Solution – Announced at Solar Power International 201923.9.2019 18:36:00 EEST | Press release
Tigo®, pioneer of the smart modular Flex MLPE & TS4 Platform, today announced its new TS4-A-2F (Fire Safety), the advanced retrofit/add-on rapid shutdown solution for two modules that provides smart PV module functionality. The TS4-A-2F is the newest, most partner adopted, and most cost-effective addition to Tigo’s advanced generation of flexible module-level power electronics in the TS4 Platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190923005637/en/ TS4-A-2F (Fire Safety) is the TS4 Platform’s newest advanced rapid shutdown solution for two modules up to 1000W and standard configuration of 1500V (Photo: Business Wire) The UL-certified TS4-A-2F complies with NEC 2017 690.12 Rapid Shutdown specifications when installed with Tigo’s UL-certified RSS Transmitter or an inverter with Tigo's built-in RSS Transmitter. The unit’s powerline communication can be easily verified with Tigo’s RSS Signal Detector. System owners c
New Generation in Cryptocurrency Mining by BitHarp23.9.2019 17:45:00 EEST | Press release
Lyre Miner and Harp Miner, two recently released cryptocurrency mining rigs from www.BitHarp.com ( BitHarp Group Limited ), are quickly turning out to be gamechangers in the global crypto market. Within their short lifespan, these two products have shown promises of revolutionizing this thriving industry by offering superfast ROI for seasoned miners as well as beginners looking to try their hand at crypto mining. The ability of Lyre Miner and Harp Miner to generate quick return on investment can be attributed to the high hash rates of the products. The term hash rate may be referred to as the speed at which a given mining machine operates. A higher hash rate increases the opportunity of a miner to find the next block and receive the reward. Making things even better for the miners, Lyre Miner and Harp Miner have significantly low energy consumptions of 600W and 2400 W respectively. The hash rate powers offered by Lyre Miner and Harp Miner are mentioned below at a glance. Lyre Miner: 33
Jabil Photonics to Demonstrate Coherent SiP based 100G/200G CFP2-DCO Product at ECOC 201923.9.2019 15:48:00 EEST | Press release
Jabil (NYSE: JBL) today announced that its Photonics business unit, a leading provider of customized end-to-end design, manufacturing and test solutions for optical communication products, will be demonstrating its coherent 100G/200G CFP2-DCO module this week at the ECOC Exhibition (Hall 4, Booth 498) in Dublin, Ireland. Jabil’s CFP2-DCO is a hot-pluggable module designed to support single-wavelength data coherent transmission at 100Gbps using DP-QPSK and 200Gbps using DP-16QAM modulations. The CFP2-DCO is designed for DWDM networks ranging from metro and data-center interconnect (DCI) to long-haul applications, as well as 100Gbps point-to-point (P2P) coherent solutions for unamplified links in 5G and cable access networks up to 80km. Powered by Elenion Technologies’ next generation Silicon Photonics (SiP) coherent engine, the Jabil Photonics CFP2-DCO sets a new standard for price-performance. The module incorporates an ultra-narrow linewidth external cavity micro-ITLA laser with gridl
CE China 2019: Suning Launches New Biu Products23.9.2019 15:43:00 EEST | Press release
Premiere at CE China: The Chinese retail giant Suning, strategic partner of CE China, has seized the opportunity to present eight new products of its Biu product line for smart home appliances at the CE China in Guangzhou. On this occasion, fans of Biu were invited to the first ever Biu fan festival to attend the launch. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190923005490/en/ Suning Launches New Biu Products at CE China 2019 (Graphic: Business Wire) Behind closed curtains, selected Biu-fans were the first to learn about the premieres of intelligent smart home products at the booth of Suning on the trade show. Among others, Suning presented the new Biu air conditioner as a “pro version”, the "Little Dolphin" electric water heater and the "Little Seashells" gas water heater. Suning representatives also showed, how the different devices connect with each other. According to Suning, Biu will continue to focus on smart pr
FLIR Introduces M300 Series Marine Cameras23.9.2019 15:00:00 EEST | Press release
FLIR Systems (NASDAQ: FLIR) today announced the FLIR M300 Series, a new generation of maritime thermal cameras delivering advanced awareness-enhancing technologies, safer navigation, and seamless integration with onboard boat systems. FLIR M300 Series cameras are designed for the most demanding professional mariners and first responders who operate in the harshest marine environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190923005214/en/ FLIR M300 Series thermal imaging cameras for professional mariners and first responders provide safer navigation and increased situational awareness (Photo: Business Wire) The successor to FLIR’s industry-leading M-Series of maritime cameras, the next generation M300 Series consists of five models featuring rugged and robust new pan and tilt housings – four models with the FLIR Boson™ resolution thermal camera cores, plus a visible-only, high-definition (HD) model. The series is hi
Mary Kay, in Collaboration With UN Agencies, Launches Women’s Entrepreneurship Accelerator23.9.2019 15:00:00 EEST | Press release
Today, Mary Kay Inc., a leading advocate of women’s empowerment and entrepreneurship, announced the Women’s Entrepreneurship Accelerator, a multi-partner initiative designed to inspire, educate, and empower women entrepreneurs around the world. With no qualifying barriers to participate, the ground-breaking initiative is a strategic collaboration developed in consultation with six United Nations agencies: UN Women, United Nations Office for Partnerships (UNOP), International Labour Organization (ILO), International Trade Centre (ITC), UN Global Compact (UNGC), and the United Nations Development Programme (UNDP). The Accelerator will offer a guided digital curriculum supplemented by on-the-ground training and mentorship. In addition, it will serve as an advocacy platform to eliminate entrepreneurial roadblocks for women, ranging from digital literacy to legal reform—enabling women to fully participate in the growth of their local and national economies. The Accelerator will support glob
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