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
Strategic Investment of NXP in Kalray3.4.2020 00:52:00 EEST | Press release
Kalray (Euronext Growth Paris : ALKAL – the “Company”), a pioneer in processors for new intelligent systems, today announces a strategic investment from NXP Semiconductors N.V. (NASDAQ: NXPI) for €8 million (approximately US$9 million), to enable the companies to develop together safe, reliable and scalable solutions for autonomous driving, combining NXP Automotive solutions and Kalray MPPA® (Massively Parallel Processor Array) Intelligent Processors. The investment will be carried out through the reserved issuance to NXP BV, a company of the NXP Group, of 503,461 ordinary shares without pre-emptive rights for the existing shareholders of the Company. Upon settlement-delivery of the new shares, the NXP Group will hold ca. 9.95% of Kalray’s share capital and voting rights. The settlement-delivery of the new shares is scheduled for April 7, 2020 and their admission to the Euronext Growth Paris multilateral trading system is scheduled for April 8, 2020. STRATEGIC NATURE OF THE TRANSACTION
Kalray: Information About Covid-193.4.2020 00:05:00 EEST | Press release
Kalray (Paris:ALKAL) (Euronext Growth Paris : ALKAL), a pioneer in processors for new intelligent systems, is sharing the status on its activity and the continuation of its activity following the various health measures taken by the French government. The impact of Covid-19 epidemic on Kalray’s research and development activity, which is not too dependent on its suppliers, is expected to be limited and Kalray is hopeful it will be able to stick to its development roadmap. The development teams are fully operational thanks to telework, which was put in place as soon as the containment was announced in France on Monday March 16. The company does not use technical unemployment to date. However, the global health situation related to the Covid-19 epidemic and the containment measures implemented in many countries are likely to slow down business cycles, which could delay the deployment of some of company’s projects. At this stage, Kalray is currently assessing all the impacts of this crisi
VDX.tv Launches Global Digital Video PSA Initiative to Inform the Public About COVID-192.4.2020 17:00:00 EEST | Press release
VDX.tv, a global advertising technology company transforming the way brands connect with relevant audiences, today launched a digital video Public Service Announcement (PSA) initiative to help drive awareness around COVID-19 and better help global communities cope with the spread of the virus. The campaign will enable corporations, brands, publishers, marketers, and celebrities to work together to help combat this spread. The initiative recognizes that this virus has and continues to impact communities globally. VDX.tv’s video ads will be translated into several languages to reach people across all regions. Additionally, VDX.tv will use its platform’s full capabilities to customize messaging in each city and provide the most relevant information. “During this unprecedented situation, we’re determined to act and help do what we do best: connect with audiences through compelling video messaging and formats,” said Dilip DaSilva, CEO, VDX.tv. “Video is the best format for brands to communi
Shareholders Approve All AGM Resolutions and SES Board Elects Frank Esser as Chairperson2.4.2020 16:14:00 EEST | Press release
SES S.A. held its Annual General Meeting (AGM) today in Betzdorf, Luxembourg, in which all resolutions were approved by shareholders. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200402005503/en/ Shareholders Approve All AGM Resolutions and SES Board Elects Frank Esser as Chairperson (Photo: Business Wire) The meeting was held based on the rules set out in the Grand Ducal Regulation of 20 March 2020 with shareholders participating remotely by appointing SES designated proxyholders to represent them at the meeting and to carry out their voting instructions given ahead of the meeting. Compliance with voting instructions was verified by the bureau of the AGM. The approved resolutions included the company's 2019 financial accounts and the proposed dividend of EUR 0.40 per A-share which will be paid to shareholders on 23 April 2020. Accordingly, SES’s 2019 Annual Report has been published and is available to download at http://
New Visualizations in Airship Journeys Offer Breakthrough Simplicity to Perfect Cross-Channel Customer Experiences2.4.2020 16:00:00 EEST | Press release
Today, customer engagement company Airship revealed new Airship Journeys visualizations that make managing in-the-moment cross-channel customer experiences dramatically simpler and more effective for marketers. Now, for the first time, marketers can quickly zero in on underperforming campaigns with high-level views of performance and journey relationships and — in a few clicks — modify messages to improve performance or connect journeys to advance other marketing goals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200402005186/en/ New visualizations in Airship Journeys condense sprawling branches of today’s journey tools into single cards that offer at-a-glance views of goal-based performance, enabling marketers to evaluate journey relationships and connect new ones to advance other goals. (Graphic: Business Wire) Airship Journeys simplifies all aspects of cross-channel customer engagement. Journey setup is guided and base
Largest Statistically Significant Study by 6,200 Multi-Country Physicians on COVID-19 Uncovers Treatment Patterns and Puts Pandemic in Context2.4.2020 16:00:00 EEST | Press release
Widespread confusion, conflicting reports, inconsistent testing, and off-indication use of existing and experimental drugs has resulted in no single source of information from the frontlines. To create a centralized and dynamic knowledge base, Sermo, the largest global healthcare polling company and social platform for physicians, leveraged its capabilities to publish results of a COVID-19 study with more than 6,200 physicians in 30 countries. The study was completed in three days. Data covers current treatment and prophylaxis options, timing to the outbreak peak, ethical choices, effectiveness of government responses, and much more. Multiple study waves including a deeper dive into treatments will be conducted over the next several weeks. To view results and countries visit sermo.com. Key findings; Sermo Real Time Barometer *: Treatments & Efficacy The three most commonly prescribed treatments amongst COVID-19 treaters are 56% analgesics, 41% Azithromycin, and 33% Hydroxychloroquine H
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