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
Lattice to Showcase Open Control Plane Innovations for AI Infrastructure at OCP Global Summit 202628.9.2026 22:00:00 CEST | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced its participation in OCP Global Summit 2026. At the event, Lattice and AMI, a Lattice company, will demonstrate how an open control plane can help organizations build secure, scalable, and manageable AI infrastructure from silicon to rack. During the event, Lattice will deliver keynote and technical presentations, showcase open management and control solutions, and host interactive demonstrations highlighting secure platform firmware, infrastructure manageability, AI rack management, quantum-resistant security, connectivity, and modular rack-scale architectures. Together, Lattice and AMI technologies will be in full display, demonstrating how organizations can build open, interoperable infrastructure capable of supporting the growing demands of AI data centers. Who: Lattice Semiconductor and AMI, a Lattice Company What / When:Keynote Presentation – “The Open Control Plane: Fro
SLB Announces Date for Third-Quarter 2026 Results Conference Call28.9.2026 19:17:00 CEST | Press release
SLB (NYSE: SLB) will hold a conference call on October 23, 2026, to discuss the results for the third quarter ending September 30, 2026. The conference call is scheduled to begin at 9:30 a.m. U.S. Eastern time and a press release regarding the results will be issued at 7:00 a.m. U.S. Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (800) 715-9871 within North America or +1 (646) 307-1963 outside of North America approximately 10 minutes prior to the start of the call and the access code is 3440360. A webcast of the conference call will be broadcast simultaneously at https://events.q4inc.com/attendee/293449855 on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until October 30, 2026, and can be accessed by dialing +1 (800) 770-2030 within North Amer
Boomi Named a Leader and Secures Highest Score in the Strategy Category in Adaptive Process Orchestration Software Evaluation28.9.2026 17:45:00 CEST | Press release
Boomi recognized as a Leader in evaluation of agentic process orchestration software Boomi™, the data activation company for AI, today announced it has been named a Leader in The Forrester Wave™: Adaptive Process Orchestration Software, Q3 2026. The report evaluated 13 providers, and Boomi achieved the highest score in the strategy category. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928931590/en/ Boomi Named a Leader and Secures Highest Score in the Strategy Category in Adaptive Process Orchestration Software Evaluation According to the report, Boomi’s “above-par roadmap is driven by a strong internal innovation process that embraces partner input and customer feedback, while recent investments focus on supporting client data sovereignty and control in geographies where sovereignty matters.” The report also cites Boomi's vendor-neutral control plane for agentic automation as allowing it to extend into the process aut
Azalea Vision Enrolls First Patient in Proof-of-Concept Study Evaluating Novel Optical Aperture for Keratoconus and Presbyopia28.9.2026 16:27:00 CEST | Press release
Azalea Vision has enrolled the first patient in its NOA proof-of-concept study, launching the company’s clinical program. The study evaluates a Novel Optical Aperture (NOA) inside a contact lens in two patient groups, keratoconus and presbyopia. Clinical study results are expected to inform the planned first-in-human evaluation of Azalea’s fully integrated smart contact lens platform in Europe and the United States. Azalea Vision, a Belgian healthtech company building the first medical-grade smart contact lens, today announced that it has enrolled the first patient in its NOA proof-of-concept study. The study marks the start of Azalea’s clinical program, following its selection for the European Innovation Council (EIC) Accelerator. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928982998/en/ Novel Optical Aperture smart lens The study is conducted at Visser Contact Lenses (Netherlands) and the University Hospital Antwerp
Xsolla Releases The Xsolla Report: Mobile D2C Edition28.9.2026 15:00:00 CEST | Press release
New Data From More Than 800 Mobile Web Shops Finds Direct-to-Consumer Has Become a Standard Operating Discipline, With Top Performers Capturing More Than Half of a Title's Revenue Regardless of Studio Size Xsolla, a global commerce company, today released The Xsolla Report: Mobile D2C Edition, a new study examining how direct-to-consumer commerce is performing across mobile games. Drawing on data from more than 800 live Xsolla Web Shops alongside public market and regulatory data, the report shows that D2C has moved past the question of whether it works and into a new phase: studios seeing the strongest results are the ones treating their Web Shop as an operating discipline rather than a one-time build. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928312597/en/ Graphic: Xsolla Three themes run through the report. First, the gap between a typical Web Shop and a top-performing one is wide, and closing it has little to do
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