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
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Lattice Sentry Solutions Stack and SupplyGuard Service Deliver End-to-End Supply Chain Protection with Dynamic Trust12.8.2020 22:00:00 CEST | Press release
Lattice Semiconductor Corporation (NASDAQ: LSCC), the low power programmable leader, today launched the Lattice Sentry™ solutions stack and the Lattice SupplyGuard™ supply chain protection service. The Sentry stack is a robust combination of customizable embedded software, reference designs, IP, and development tools to accelerate the implementation of secure systems compliant with NIST Platform Firmware Resiliency (PFR) Guidelines (NIST SP-800-193). The Lattice SupplyGuard service extends the system protection provided by the Sentry stack throughout today’s challenging and rapidly changing supply chain by delivering factory-locked devices to protect them from attacks like cloning and malware insertion, and enables secure device ownership transfer. These hardware security solutions are increasingly important to a range of applications, including communications, datacenter, industrial, automotive, aerospace, and client computing. This press release features multimedia. View the full rel
Phase III InPedILD™ trial enrolls first patient to evaluate nintedanib in pediatric population with fibrosing interstitial lung disease12.8.2020 14:36:00 CEST | Press release
Boehringer Ingelheim today announced that the first patient has enrolled in InPedILD™, a global Phase III trial assessing the dosing and safety profile of nintedanib in children and adolescents between six and 17 years old with clinically significant fibrosing interstitial lung disease (ILD). Childhood ILD (chILD) includes more than 200 rare respiratory disorders that can affect infants, children and adolescents, making it difficult for them to breathe. In some cases, fibrosis which involves scarring and damage to the lungs can develop. This can lead to a significant impact on the daily life of those affected, as well as their families, including high morbidity and mortality. There are currently no approved therapies available for the treatment of chILD. “Some children with interstitial lung disease may develop serious fibrosis that progresses,” said the coordinating investigator Prof. Robin Deterding, M.D., Director of the Breathing Institute, Children's Hospital Colorado. “Though the
Velodyne Lidar Powering Intelligent Traffic Management in Nevada12.8.2020 14:00:00 CEST | Press release
Velodyne Lidar, Inc. today announced a partnership with University of Nevada, Reno to advance research in transportation infrastructure. The university’s Nevada Center for Applied Research purchased and, in conjunction with the Nevada DOT and Nevada Governor’s Office of Economic Development, is using Velodyne’s lidar sensors in its Intelligent Mobility initiative to collect data aimed at making transportation more efficient, sustainable and safe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200812005076/en/ The University of Nevada, Reno’s Nevada Center for Applied Research has integrated Velodyne Ultra Puck lidar sensors with traffic signals to detect, count and track pedestrians, cyclists and traffic. (Photo: Velodyne Lidar, Inc.) The program has integrated Velodyne Ultra Puck lidar sensors with traffic signals to detect, count and track pedestrians, cyclists and traffic to help improve traffic analytics, congestion mana
Moody’s Analytics Three-Peats in Two Categories at Risk Technology Awards12.8.2020 13:30:00 CEST | Press release
For the third straight year, Moody’s Analytics has won the Risk Technology Awards for Credit Data Provider of the Year and Wholesale Credit Modelling Software of the Year. These are two of our seven 2020 Risk Technology Awards spanning finance, accounting, regulatory, and credit functions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200812005119/en/ “Our clients rely on Moody’s Analytics for a fast and comprehensive view of their credit risk exposure,” said Nihil Patel, Managing Director at Moody’s Analytics. “The pandemic has accelerated their need to consider multiple forward-looking signals to assess credit risk. We continue to invest—in more asset class coverage, in alternative data sources, in machine learning that produces new analytics and insights—to ensure that our clients have all the information they need to address their most pressing business needs.” Extensive credit data and modeling capabilities feature in
Imricor Announces Sales Collaboration with Optoacoustics12.8.2020 13:00:00 CEST | Press release
Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR), the global leader in MRI-guided cardiac ablation products, is pleased to announce a sales collaboration with Optoacoustics Ltd, the world leader in innovative, high performance optical communication solutions for magnetic resonance (MR) applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200812005231/en/ Imricor Announces Sales Collaboration With Optoacoustics (Photo: Business Wire) The collaboration establishes a formal relationship between Imricor and Optoacoustics to facilitate the introduction of the IMROC IRTM Wireless Multichannel Communication System to Imricor customers. IMROC provides wireless noise cancelling MRI headsets that can be used by up to 8 participants simultaneously, including the patient. The system was developed specifically for use in iCMR environments. Given the noise and complexities of MRI, normal conversation can be difficult d
Samsung Display Commercializes New, Variable Refresh Rate Technology for Increasing Smartphone Power Savings12.8.2020 10:19:00 CEST | Press release
Samsung Display Company today revealed new display technology that features a remarkable power-saving function for mobile electronics, being commercialized for the first time in Galaxy Note 20 Ultra 5G flagship smartphones. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200812005278/en/ Engineers from Samsung Display are using testing devices to inspect frequency changes in display panels that feature adaptive frequency technology (Photo: Business Wire) The display company has now successfully commercialized its low-power OLED adaptive frequency technology, which can curtail the operating power of a phone’s display by as much as 22 percent over existing smartphones now in general use. “High-definition video streaming and gaming are expanding their capabilities in line with 5G commercialization, creating a widespread need for display panel technologies that can enable greater power savings,” said Ho-Jung Lee, Vice President o