Samsung Bioepis Enters into Commercialization Agreement for Next-Generation Biosimilar Candidates
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
Morningstar's 2026 Outlook Report Delivers Global and Regional Insights for Durable Portfolios17.11.2025 16:00:00 EET | Press release
Morningstar, Inc. (Nasdaq: MORN), a leading provider of independent investment insights, today published its 2026 Outlook, offering an overview of key challenges and opportunities for the year ahead. In a market defined by uncertainty, this year’s report emphasizes the value of preparation over prediction, equipping investors with strategies to focus on fundamentals and help build resilient portfolios that withstand both booms and busts. Drawing on insights from Equity, Manager, and Behavioral research analysts worldwide, this Outlook distills Morningstar’s thinking on how to navigate opportunity and risk across every major asset class in 2026. "Markets are unpredictable, and the geopolitical and tariff uncertainty of 2025 showed just how quickly forecasts can shift. That’s why Morningstar is redefining the Outlook, focusing on durable portfolios rather than short-term predictions,” said Dan Kemp, chief research and investment officer. “No matter what market conditions the year ahead m
Wolters Kluwer Enablon Control of Work Solution Now Available as Private Offer in AWS Marketplace17.11.2025 16:00:00 EET | Press release
Wolters Kluwer today announced that its Enablon Control of Work solution is now available in AWS Marketplace as a private offer. This purchasing model empowers customers to negotiate and receive tailored pricing, terms, and licensing agreements, while streamlining procurement and leveraging existing Amazon Web Services (AWS) billing workflows to accelerate deployment and optimize cloud budgets. Wolters Kluwer’s Enablon Control of Work solution consolidates permit-to-work, isolation management and risk assessments into an integrated system. Trusted by frontline workers and contractors in high-risk environments including oil & gas, pharmaceuticals, data center and manufacturing industries, the software helps streamline operations, minimize unplanned downtime and prevent serious injuries and fatalities. Richard Pulliam, SVP & General Manager of EHS & ESG for Wolters Kluwer, said: “Making Enablon's Control of Work solution available in AWS Marketplace is another step in our mission to help
World First: Autonomous Racing Leaps Forward in Abu Dhabi as A2RL Season 2 Showcases Record Speed, Bold Overtakes and Real-Time AI Decision-Making17.11.2025 15:50:00 EET | Press release
The Abu Dhabi Autonomous Racing League, A2RL, delivered a defining moment for autonomous technology as six fully driverless racecars pushed the limits of AI performance in a world-first Grand Final at Yas Marina Circuit. In a night marked by record speed, bold overtakes, and split-second AI decision-making, Germany’s TUMcemented its dominance by retaining the championship title, followed by TII Racing (UAE) in second place, and PoliMOVE (Italy) in third. With eleven international teams battling for a $2.25 million prize pool and a Human vs AI showdown featuring former F1 star Daniil Kvyat, the event showcased just how dramatically the race - and the technology behind it - has advanced since Season 1. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117644875/en/ World First: Autonomous Racing Leaps Forward in Abu Dhabi as A2RL Season 2 Showcases Record Speed, Bold Overtakes and Real-Time AI Decision-Making (Photo: AETOSWire
87% of Institutional Investors Have Declined or Reconsidered Fund Commitments Due to AML/KYC Concerns17.11.2025 15:30:00 EET | Press release
Nearly nine-in-10 (87%) limited partners (LPs) have declined or reconsidered a fund allocation due to anti-money laundering and Know Your Customer (AML/KYC) concerns, underscoring just how significant compliance has become as a gatekeeping item for fundraising. According to a new study by CSC, the leading provider of global business administration and compliance solutions, general partners (GPs) are already feeling the strain. Almost two-thirds (63%) report losing investors or reinvestments due to AML/KYC shortcomings, most commonly from documentation gaps (61%) and onboarding delays (24%). CSC surveyed 200 GPs and 200 LPs across North America, Europe, the U.K., and Asia Pacific to capture views on the evolving compliance landscape.1 The findings are detailed in CSC’s report, “Beyond Compliance: How AML/KYC is Redefining Investor Confidence.” The study found that LPs are setting the pace when it comes to AML/KYC. 88% said they’re more likely to invest in a manager with a formal AML/KYC
Cardano Summit 2025 Concludes In Berlin: Trust Emerges As The Winner with Traditional Financial Firms Feeling Blockchain FOMO17.11.2025 15:23:00 EET | Press release
Last week’s Cardano Summit 2025 at Berlin’s iconic Gasometer heard from 140 speakers, brought together close to 800 attendees from over 70 countries, and attracted over 25,000 online participants, showcasing significant momentum in enterprise blockchain adoption. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117496852/en/ Cardano Foundation CEO Frederik Gregaard on the main stage at the Cardano Summit 2025 in Berlin Across two days of strategic discussions, enterprise leaders joined the Cardano community to discuss industry readiness, DeFi expansion, and the convergence of AI with distributed systems. The Cardano Foundation also outlined its 2026 roadmap highlighting decentralized finance (DeFi) liquidity, Web3 integration, and real-world asset (RWA) tokenization as key focus areas. Additionally, Singapore was unveiled as the location for next year’s Summit. Cardano Foundation CEO Frederik Gregaard set an ambitious tone
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