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
U.S. Federal Court Permanently Bans 19 Online Sellers of Fake Urolithin A Supplements and Awards $5.3 Million in Damages to Timeline23.7.2026 17:27:00 EEST | Press release
Timeline (Amazentis SA), the Swiss life-sciences company that pioneered the postbiotic ingredient Urolithin A and its branded form Mitopure®, together with its U.S. subsidiary Timeline Longevity, Inc., announced today that the U.S. District Court for the District of Massachusetts has granted the companies’ motion for default judgments and permanent injunctions against 19 online sellers found to have marketed and sold nutritional supplements falsely advertised as containing Urolithin A. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722951066/en/ Timeline longevity supplement powered by Mitopure; proprietary, highly pure Urolithin A. The order, entered July 15, 2026 by Judge Myong J. Joun in Amazentis SA et al. v. The Partnerships and Unincorporated Associations Identified on Schedule “A”, Case No. 1:25-cv-12913-MJJ (District of Massachusetts), permanently enjoins 19 defaulting defendants from further manufacturing, market
TestMu AI Introduces the Source-to-Verdict Loop in Kane CLI, Carrying Every Requirement to a Ship Decision With Portable Proof23.7.2026 16:45:00 EEST | Press release
TestMu AI (formerly LambdaTest), the world's first Agentic AI-powered Quality Engineering platform, introduced a source-to-verdict loop in Kane CLI, its natural-language testing tool. Building on Kane CLI's evolution from a browser automation tool, the loop carries a product requirement to a ship decision, writing the tests, running them in the local browser, collecting the proof, measuring coverage from what actually happened, and returning a verdict. As AI agents write, run, and fix tests, a green checkmark is no longer enough: a step that checks nothing passes, a test written against a spec that changed weeks ago passes, and an agent that says “done” without the click ever landing passes. Empty green and earned green are the same color on every dashboard, the number climbs while the risk does not move. Kane CLI closes that gap: it carries a requirement to a verdict, and proves every step of it. One loop. Source to verdict. You no longer hand Kane CLI a test script, you hand it your
Norway’s health system adopts Wolters Kluwer UpToDate Enterprise Edition23.7.2026 16:30:00 EEST | Press release
Wolters Kluwer Health announced that Norway’s health system has renewed its adoption of UpToDate Enterprise Edition, a market-leading Clinical Decision Support (CDS) solution, for its nationwide health system which includes over 50 public hospitals and 11,000 beds in over 20 trusts. This extends a 15 year partnership with Helsebiblioteket, now part of the Norwegian Institute of Public Health (NIPH). Helping clinicians on a national scale Kjell Tjensvoll, Team Leader for Helsebiblioteket said, ‘‘Providing frontline teams with easy access to the latest medical knowledge is vital in reducing unwarranted variation and improving patient care on a national scale. UpToDate Enterprise Edition enables this, and we are delighted to strengthen our relationship with Wolters Kluwer and provide continued support for clinicians across the country.’’ UpToDate Enterprise Edition was selected by Helsebiblioteket, the Norwegian Electronic Health Library. The selection followed a competitive process by th
Boyd Watterson Global Names John Creswell Global Chief Client Officer to Accelerate Global Growth and Client Engagement23.7.2026 16:00:00 EEST | Press release
Boyd Watterson Global today announced the appointment of John Creswell as Global Chief Client Officer, a newly created senior leadership role that reflects the firm's continued investment in growth and its evolution into a leading global alternatives investment platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722823117/en/ John Creswell has joined Boyd Watterson Global as Global Chief Client Officer, a newly created role overseeing global sales, client engagement and marketing across the U.S., Europe and APAC. In this role, Creswell will oversee global sales, client engagement and marketing efforts across the United States, Europe and APAC, helping investors access the firm's capabilities while strengthening relationships with institutional and private capital partners worldwide. While based in Chicago, John will spend considerable time at the firm’s headquarters in Cleveland as well as in key offices globally. Cr
Trulioo Launches AI Agent to Resolve Beneficial Ownership Where Global Registries Fall Short23.7.2026 16:00:00 EEST | Press release
Trulioo, a global risk intelligence platform, today announced the UBO Discovery Agent, the newest layer in Trulioo's UBO Discovery capability inside its business risk and Know Your Business (KYB) verification workflow. AI is reshaping fraud, making it easier for bad actors to hide, and harder for companies to catch them. This makes the already tough job of verifying who actually owns a business even more difficult. Determining a business's ultimate beneficial owner is an ongoing, acute challenge for companies: registry coverage is inconsistent across countries, and even where registries exist, they typically record shareholders and directors of record (rather than the people actually in control). That data isn't simply outdated, it reflects a structural lag: ownership changes and time passes before the filing is made and processed, so a lookup often shows who owned a business months or years ago, not who owns it today. Further, ownership chains that cross borders can break entirely onc
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