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
Sindre Zeiner-Gundersen Joins Joi Scientific12.2.2026 21:00:00 EET | Press release
Joi Scientific is pleased to welcome Sindre Zeiner-Gundersen as the company’s Advanced Plasma & Resonant Energy Physicist. Sindre will lead Joi’s scientific activities including all aspects of Joi’s science program. Sindre is a quantum physics expert who previously served as CEO/President of Nornec AS, a Norwegian consulting and engineering services company. Nornec has been a consultant to Joi since 2024. At Nornec, Sindre provided consulting and R&D services in the areas of advanced nuclear reactor simulations, process and plant optimization, carbon capture optimization, materials selection and radiation effects, custom reactor design, muon and neutron detector systems, muon and catalyzed fusion and Hydrogen Rydberg Matter research. An applied physicist with end‑to‑end expertise in energy‑carrier gases - ammonia, methanol, hydrogen - as well as a radiation instrumentation specialist with experience in process and equipment design across the ammonia/hydrogen value chain, Sindre has aut
Angelalign Technology Inc. (6699.HK) Says a Preliminary European Court Ruling on Certain Software Features Will Have Minimal Impact on Users12.2.2026 18:58:00 EET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel”) said a ruling by the Unified Patent Court of Düsseldorf, Germany that it preliminarily cease its use of certain software functions that automatically update treatment plans would have minimal impact on the orthodontists and patients who use its clear aligner products. The ruling applies to certain European countries and excludes Spain, Switzerland, United Kingdom and Ireland. Angel will launch iPlan for applicable European users, which is an upgrade feature that has the same reliability and more flexibility for users. Angel denies that the Live Now feature in its iOrtho treatment planning software infringes any valid patents of Align Technology Inc. (ALGN). Angel has already filed an opposition against the patent with the European Patent Office (EPO), arguing that the claimed invention is neither novel nor inventive over the prior art, and is seeking its permanent invalidation. Angel is confident it will overcome the first-instance, non-fi
Model ML Buys Captide to Give Financial AI Agents Citable Corporate Disclosure Data12.2.2026 18:43:00 EET | Press release
Model ML today announced the acquisition of Captide, the leading financial data layer that turns complex global corporate filings and disclosures into LLM-ready documents and data for AI agents. The acquisition, just weeks after the fintech raised $75m in funding from leading US and UK investors, expands Model ML’s AI workflow builder, enabling its AI agents to reliably retrieve, reason over, and cite global filings. Earlier in 2025, Model ML bought Flippr which added automated PowerPoint generation and verification agents to the platform. Founded in 2024 by Maurits Brinkman and Miquel Trafí Ruiz, Captide’s API takes SEC filings, earnings calls and more and structures them in a way AI models can easily and accurately understand at scale. Its platform already spans 2.5 million+ documents and supports 1 billion embeddings. By bringing Captide into Model ML, clients – including Big 4 accounting firms, consulting companies and top-tier global financial institutions – can now access this di
Andersen Global Adds Collaborating Firm Pi Advisory12.2.2026 16:30:00 EET | Press release
Andersen Global strengthens its capabilities in Africa through a Collaboration Agreement with Pi Advisory, a financial advisory firm based in Angola with a presence in Mozambique and Portugal. Pi Advisory provides a comprehensive suite of services, including full-service tax services, business support and outsourcing, financial advisory, and a wide range of corporate services to support clients with everything from setting up a new business entity to navigating local tax regulations. The firm integrates Environmental, Social, and Corporate Governance (ESG) principles into its operations, reflecting its commitment to sustainable business practices. “This collaboration strengthens our ability to support clients with complex, multi-jurisdictional needs,” said António Amaral Correia, partner at Pi Advisory. “By collaborating with Andersen Global, we can provide solutions that meet the evolving demands of clients in Lusophone markets and beyond.” Mark L. Vorsatz, global chairman and CEO of
i2c Named Finalist for Best Security or Anti-Fraud Development at Card & Payments Awards Middle East 202612.2.2026 16:00:00 EET | Press release
i2c Inc., a global financial technology innovator, has been named a finalist in the Best Security or Anti-Fraud Development category at The Card & Payments Awards Middle East 2026. The region’s premier awards program recognizes organizations that deliver practical, high-impact innovations to strengthen payment security and protect customers in one of the world’s fastest-growing digital payments markets. i2c was recognized for its AI-driven Fraud Risk Management solution, embedded directly within its unified banking and payments platform and operating in real time at the point of transaction authorization—an increasingly critical capability as digital payments scale across Middle East markets. By evaluating risk at the moment a payment is initiated, rather than after funds are approved, the solution enables earlier detection of fraudulent activity while preserving approval rates and minimizing friction for legitimate customers. Designed for digital‑first economies where fraud evolves qu
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