Business Wire

Samsung Bioepis Continues Global Expansion, Enters Brazilian Biopharmaceutical Market with BRENZYS™ (etanercept)

Share

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.

Contact information

Na Yun Kim
+82-31-8061-1604
nayun86.kim@samsung.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

Metanoia Announces Its Next Generation Broadband Access Technology14.10.2019 07:11:00 CESTPress release

BROADBAND WORLD FORUM 2019--In order to respond to the ever increasing demand for higher data rate of xDSL over copper, coax lines, Metanoia Communications (“Metanoia”) announced today the launch of its latest family of chipsets that supports all the ITU-T Gfast (212MHz profile) and VDSL2 (35MHz profile) standards and builds on Metanoia’s proven Gfast, VDSL2 and ADSL2/2+ technology. With its MT-x2331 product family, Metanoia will deliver the industry first next generation broadband access xDSL PHY chipset for multiple applications including home gateways, low density xDSL Central Office systems and standalone xDSL termination, such as SFP modules. Emerging trends in the Broadband Access Networks make the use of standalone xDSL PHY solution more pertinent for WAN PHY agnostic platforms. A standalone xDSL PHY enables cost-effective upgrade of existing WAN deployments, an approach which is increasingly attractive to Operators. Metanoia MT-x2331 series is a chipset family that supports all

BIZCENTER USA Launches Coworking Facility in Orlando With Plans for Nationwide Franchise14.10.2019 04:01:00 CESTPress release

Multimedia, Inc. (www.multimediausa.com) starts today the operations of BIZCENTER USA LLC, its affiliate for shared workspaces and virtual offices. Located on a fully owned 4,400 sq. ft. area in one of the most strategic regions of Orlando, Florida, BIZCENTER USA is offering brand-new state of the art executive suites in a facility with upscale conference rooms, reception, luxury lounge, and kitchen. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191013005018/en/ Founded in Orlando in 1991, Multimedia is a leading marketing and communications company, highly recognized worldwide for its professional integrity, serving advertising agencies, direct clients and media outlets across all continents. According to Fernando Mariano, president of both companies, the creation of BIZCENTER USA fulfills the needs for a stylish shared workspace and virtual office facility in Southwest Orlando. “Multimedia has strong ties with the Orlando

Vodafone Idea and Mavenir Partner to Extend Network as a Platform14.10.2019 01:00:00 CESTPress release

Mavenir, the industry's only end-to-end cloud-native 4G and 5G network software provider for CSPs today announced the extension of its partnership with Vodafone Idea Limited (VIL), India’s leading telecom operator, to extend VIL Network as a Platform, reaching distributed presence across all the major Industrial, Commercial, and Services clusters in India. This partnership will focus on three thrust areas. First, building a universal secured Cloud capable of hosting multiple tenants and third-party applications. Second, building a fully automated platform that enables self-provisioning of various workloads. Third and most importantly, setting up a joint innovation lab and team that will consistently innovate on Chipset, Operating System, and work at Application level to offer unique APIs and enable new use cases and delightful experience to VIL customers. “Vodafone Idea has the largest Edge Cloud deployment in India. Our partnership with Mavenir will enable continued innovation in opti

SHINE Creates Therapeutics Division, Will Attend 2019 European Association of Nuclear Medicine Conference12.10.2019 04:00:00 CESTPress release

SHINE Medical Technologies, LLC today announced the creation of a new division of the company — SHINE Therapeutics. The establishment of the division enhances the company’s ability to focus on filling critical future needs in the rapidly growing therapeutic isotope market, while continuing to leverage its radioisotope production expertise. The company’s Therapeutics division will initially focus on the development and commercialization of lutetium‑177, or Lu‑177, a therapeutic isotope that is combined with a disease-specific targeting molecule to treat cancer. Targeting molecules deliver Lu‑177 atoms to cancer sites throughout the body, where they directly irradiate cancer cells. The first Lu‑177-based targeted radiotherapy (for neuroendocrine tumors) reached the market in 2018. Many high-potential targeted molecules for the treatment of a range of other cancers with Lu-177 are currently under investigation. SHINE is also evaluating additional medical isotopes with therapeutic properti

Smart Taxation – A Step Towards a Fair, Efficient and Growth-Friendly European Taxation Approach11.10.2019 22:01:00 CESTPress release

In a rapidly changing global economy, smart taxation is essential to drive growth and economic prosperity. However, the European Union (EU) continues to fall behind as it persists with a one-size-fits all taxation system. This year’s GLOBSEC Tatra Summit hosts a Focus Group, bringing together international experts, looking to reshape and support a smarter European tax policy. Europe is at a crossroads in adapting its tax policy to the realities of today’s global economy. The EU plays a key role in overseeing national tax rules in some areas - particularly in relation to EU business and consumer policies. The institutional changeover marks a perfect opportunity for the Tatra Summit to place major topics on the radar of decision-makers and offer efficient recommendations. So now is the time to adapt the EU’s taxation model to be fit-for-purpose. With member states around the table, European fiscal authorities should design a model that does not have a disruptive impact on national needs

Clovis Oncology Announces Rubraca®▼ (rucaparib) Now Available for Women with Relapsed Ovarian Cancer in England Through the Cancer Drugs Fund11.10.2019 13:19:00 CESTPress release

Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the National Institute for Health and Care Excellence (NICE) has recommended that women with relapsed ovarian cancer in England have access to rucaparib through the Cancer Drugs Fund (CDF).1 Rucaparib is available for use within the CDF as an option for the maintenance treatment of relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy in adults, based on the conditions outlined in the managed access agreement. "Ovacome welcomes the availability of rucaparib via the CDF as an option for maintenance treatment of platinum-sensitive relapsed high grade serous epithelial ovarian cancer regardless of BRCA status or line of treatment in the relapsed maintenance setting,” said Victoria Clare, CEO of Ovacome, a United Kingdom ovarian cancer charity focused on providing support to anyone affected by ovarian cancer. “It is vital that the exp