Samsung Bioepis Enters into Commercialization Agreement for Next-Generation Biosimilar Candidates
6.11.2019 15:46:00 EET | Business Wire | Press release
Samsung Bioepis Co., Ltd. announced today that it has entered into a new commercialization agreement with Biogen (Nasdaq: BIIB) for two biosimilar candidates under development by Samsung Bioepis, SB11 (ranibizumab) and SB15 (aflibercept), in the United States (US), Canada, Europe, Japan, and Australia. SB11, a biosimilar candidate referencing LUCENTIS®ii (ranibizumab), is undergoing phase 3 clinical trial, while SB15, a biosimilar candidate referencing EYLEA®iii (aflibercept), is in pre-clinical development.
In addition, the agreement provides Biogen an option to extend the commercialization term for Samsung Bioepis’ three anti-TNF biosimilars – BENEPALI™ (etanercept), FLIXABI™ (infliximab), and IMRALDI™ (adalimumab) – in Europe for additional five years, extending the original ten-year agreement.1 BENEPALI™ is the most prescribed etanercept in France, Germany, Italy, Spain, and the United Kingdom (UK).iv IMRALDI™ is the leading adalimumab biosimilar in Europe.iv
The agreement also provides Biogen an option to receive commercialization rights to BENEPALI™, FLIXABI™ and IMRALDI™ in China in exchange for royalties on sales in the market.
The agreement is a testament to Samsung Bioepis’ strong track record in the field of biosimilars and the potential value that Samsung Bioepis’ ophthalmology biosimilars could deliver to patients and healthcare systems across the world. Under the agreement, Samsung Bioepis will receive upfront payments of USD 100 million, up to USD 270 million in milestone/option payments, as well as sharing of sales revenue. Samsung Bioepis will be responsible for development, regulatory registration, and manufacture of the products, while Biogen will be responsible for commercialization.
“In Europe, we have been very pleased with Biogen’s commercialization efforts with our anti-TNF medicines, fulfilling the mission of expanding access to high-quality medicines to patients across Europe. By building on this collaboration, we are excited to potentially expand the opportunity for patients living with ophthalmological conditions, who don’t have access to life-changing medicines,” said Christopher Hansung Ko, President and Chief Executive Officer, 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 healthcare systems across the world.”
Samsung Bioepis’ products are now available across Europe, North America, 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). 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.
1 The effective dates of commercialization differ for each anti-TNF product based on the launch dates. BENEPALI ™ and FLIXABI ™ were launched in Europe in January and May 2016, respectively, while IMRALDI ™ was launched in October 2018 in Europe.
About BENEPALI™ (etanercept)
BENEPALI™ (etanercept), a biosimilar referencing ENBREL®v, was approved by the European Commission (EC) in January 2016 for the treatment of adults with moderate to severe rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis, pediatric plaque psoriasis. BENEPALI™ is currently available in 25 countries in Europe and is the most prescribed etanercept in France, Germany, Italy, Spain and the United Kingdom.iv
About FLIXABI™ (infliximab)
FLIXABI™ (infliximab), a biosimilar referencing REMICADE®vi, was approved by the European Commission (EC) in May 2016 for the treatment of adults with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis or psoriasis. FLIXABI™ can also be used in patients 6-17 years old with severe, active Crohn’s disease or severely active ulcerative colitis when they have not responded to or cannot take other medicines or treatments. FLIXABI™ is currently available in 17 countries in Europe.iv
About IMRALDI™ (adalimumab)
IMRALDI™ (adalimumab), a biosimilar referencing HUMIRA®vii, was approved by the European Commission (EC) in August 2017 for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, uveitis, and pediatric uveitis. IMRALDI™ is currently available in 19 countries in Europe and is the leading adalimumab biosimilar in Germany and in Europe year to date 2019. iv, viii
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 and follow us on social media – Twitter, LinkedIn.
i Data on file: Biogen, Inc. Third Quarter 2019 Financial Results and Business Update, Oct 22, 2019
ii LUCENTIS® is a registered trademark of Genentech
iii EYLEA® is a registered trademark of Regeneron Pharmaceuticals
iv Data on File: IQVIA, GERS, Insight Health ODV
v ENBREL® is a registered trademark of Pfizer/Amgen
vi REMICADE® is a registered trademark of Janssen
vii HUMIRA® is a registered trademark of AbbVie
viii Data on File: Biogen data on file
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191106005515/en/
Contact information
MEDIA CONTACT:
Na Yun KIM
+82-31-8061-1604
nayun86.kim@samsung.com
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
New INRIX Parking Scorecard Reveals Cities with the Most Parking, Highest Prices, and Lowest Availability7.10.2026 23:16:00 EEST | Press release
INRIX, a leader in transportation analytics and mobility intelligence, today released its first-ever INRIX Parking Scorecard, the largest comparative analyses of downtown parking conditions across North America and Europe. Drawing on parking availability, curb regulations, pricing data and parking infrastructure from more than 120 downtown areas in 14 countries, the report reveals significant differences in parking conditions and how cities allocate curb space. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007322796/en/ New INRIX Parking Scorecard: Where Downtown Parking Costs Most The Scorecard examines parking availability: the probability of finding a parking space alongside on-street and off-street parking pricing, and curb use policies. The findings show that parking conditions vary dramatically between cities, both overall and by time of day and day of the week, with implications for everything from the driver expe
Lattice Collaborates with Arm to Advance Secure, Adaptable AI Data Center Infrastructure7.10.2026 23:00:00 EEST | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced a collaboration with Arm to enable secure control, management, and platform adaptability for AI infrastructure. Combining Arm® AGI CPU server platforms with Lattice FPGAs and AMI firmware creates a solution that provides advanced security, manageability, connectivity, and flexibility for next-generation AI data center infrastructure. In Arm AGI CPU server platforms, Lattice FPGAs work alongside the CPU and baseboard management controller, with AMI firmware providing platform boot and management capabilities. The Lattice FPGAs act as companion chips providing secure control and management capabilities, enabling platform trust, connectivity, and infrastructure adaptability. Lattice FPGA technology also enables Open Compute Project (OCP)-compliant connectivity between the Host Processor Module (HPM) and Datacenter Secure Control Module (DC-SCM) through the LVDS Tunneling Protocol
Bentley Systems Announces Winners of the 2026 Year in Infrastructure Awards7.10.2026 20:55:00 EEST | Press release
(The Bentley Systems 2026 Year in Infrastructure Event) – Bentley Systems, Incorporated (Nasdaq: BSY), the infrastructure engineering software company, today announced the winners of the 2026 Year in Infrastructure Awards. For more than 20 years, the awards have honored the extraordinary work of infrastructure professionals and their innovative use of Bentley software to improve how infrastructure is designed, built, and operated. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007964087/en/ Bentley Systems announced the winners of the 2026 Year in Infrastructure Awards on October 7, 2026 (Photo courtesy of Bentley Systems) In 2026, over 300 projects were nominated by organizations in 53 countries. Winners were selected across 12 categories spanning the infrastructure lifecycle, industries, and disciplines by a panel of independent judges during the Bentley Systems 2026 Year in Infrastructure Event, held October 6-7 in Sin
Day One Strategy Founders Recognised in The LDC Top 50 Most Ambitious Business Leaders for 20267.10.2026 20:00:00 EEST | Press release
Hannah Mann and Abigail Stuart, Co-Founders of Day One Strategy have been recognised as one of The LDC Top 50 Most Ambitious Business Leaders for 2026. The programme was created by private equity investor LDC, part of Lloyds Banking Group, in partnership with The Times. Since 2018, it has celebrated the ambition and achievements of hundreds of exceptional entrepreneurs. This year The LDC Top 50 attracted more than 620 nominations from across the UK, highlighting the depth of ambition among leaders building successful businesses in every region and sector. The leaders featured are driven by an appetite for growth that is helping to build stronger, more sustainable businesses and a more competitive UK economy. They are expanding internationally, developing new products and services, challenging established markets and investing in their people. Together, their businesses generate £1.4bn in annual revenues and employ almost 8,500 people. Headquartered in 55 towns and cities, they demonstr
TestMu AI Adds Evidence Packs to Kane CLI, Turning Every AI Test Run into One Portable, Shareable File7.10.2026 17:29:00 EEST | Press release
TestMu AI (formerly LambdaTest), the Full Stack Agentic AI Quality Engineering platform, announced evidence packs for Kane CLI, its terminal-first tool for natural language browser and mobile app testing. Every Kane CLI run now produces one sealed .evidence file that holds the complete record of what the AI agent was asked to do, what it did at each step, and what happened. Kane CLI launched in April 2026, giving developers and AI coding agents a way to run tests on real browsers and mobile apps from the terminal, in plain English, with a clear pass-or-fail verdict. Since launch, it has added AI-powered test case generation and the Assurance Lifecycle, which ties tests back to requirement documents. Evidence packs are the next step: a full record of every run. As AI agents write and run more tests, engineering teams need a clear answer to a simple question: what exactly did the agent do, and why did the run pass or fail? That proof is often spread across screenshots, log folders, and d
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