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
Tigo Energy Adds Dynamic Rate Management for EI Residential Solar-Plus-Storage Solution in EU9.12.2025 06:00:00 EET | Press release
Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced the addition of Dynamic Rate Management to the Tigo EI Residential solar-plus-storage solution. This new capability enables Tigo all-in-one ecosystem to intelligently respond dynamically to changes in electricity rates. This addition of Dynamic Rate Management comes at a time when European energy companies are rapidly expanding the use of dynamic rates across several EU nations. The Dynamic Rate Manager will be available for new Tigo EI customers as well as existing EI Residential system owners as a part of a software update with no additional hardware, accessories, or configuration required. The Dynamic Rate Management feature allows the EI Residential solution to automatically acquire and interpret wholesale dynamic energy prices, often updated on a day-ahead basis, and plan system behaviour to optimize the use of solar, battery, and grid powe
SII Begins Mass Production of the World’s Smallest (1.0 × 0.8 × 0.32mm) Tuning-Fork Crystal Resonator “SC-10S”9.12.2025 04:00:00 EET | Press release
Seiko Instruments Inc. (President: Yoichi Endo; Headquarters: Chiba City, Chiba Prefecture; hereinafter “SII”) will begin mass production of the “SC-10S” (32.768kHz), the world’s smallest* tuning-fork crystal resonator measuring 1.0 × 0.8mm, starting in April 2026. *Based on SII research as of November 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251202800779/en/ Product Image-1 [Background of Development] SII has already been mass-producing the “SC-12S” (32.768kHz), one of the world’s smallest tuning-fork crystal resonators at 1.2 × 1.0mm. As wearable devices such as smart rings and smartwatches, as well as IoT devices, continue to become smaller, the electronic components built into these devices are increasingly required to support high-density mounting, low power consumption, and high performance. To meet these needs, SII leveraged its proprietary photolithography technology to develop and mass-produce the world’
Verimatrix: Signing of an Agreement for the Sale of XTD Assets (Code and Application Protection) to Guardsquare8.12.2025 18:45:00 EET | Press release
Regulatory News: VERIMATRIX (Euronext Paris: VMX, FR0010291245), a leading provider of user security solutions for a safer connected world, announces the signing of an agreement with Belgium-based Guardsquare, the leading provider of mobile application security, for the sale of its Extended Threat Defense (XTD) assets. Guardsquare, the creators of the open-source optimization tool, ProGuard, offers the most complete mobile application security platform on the market spanning automated testing and multi-layered protection, real time threat monitoring, and app attestation. Guardsquare’s 975+ customers are located in more than 95 countries and represent all major industries. Launched in 2021, Verimatrix's Extended Threat Defence (XTD) business is composed of a group of cybersecurity experts specialised in protecting mobile, web and desktop applications. Using a range of innovative solutions, XTD solutions predict, detect and respond to threats before their targets are compromised. Over th
WNBA Champion Sabrina Ionescu Becomes Global Brand Ambassador for Ant International8.12.2025 18:00:00 EET | Press release
Four-time WNBA All-Star Sabrina Ionescu today becomes a new Global Brand Ambassador for Ant International, a leading global provider of digital payments, digitisation, and financial technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251208536426/en/ The partnership is built on a shared commitment to creating a more inclusive and sustainable world through empowering underserved communities and youth groups with sports and technology innovation. It marks an important step in Ant International’s journey to foster growth and expand access to financial tools through innovative technology. Ionescu serves as the first Ant International global brand ambassador from North America. “Sabrina embodies the spirit of perseverance and the passion for excellence that is driving young talents and small businesses around the world to uplift their communities,” said Douglas Feagin, President of Ant International. “As a legend in a spor
SABCS 2025: REVEAL GENOMICS Presents Major Advance in Predicting Brain Metastasis in HER2+ Breast Cancer8.12.2025 17:20:00 EET | Press release
REVEAL GENOMICS, S.L., a Barcelona-based biotechnology company focused on advancing precision oncology through biomarker innovation, announced today the presentation of seven studies at the upcoming San Antonio Breast Cancer Symposium (SABCS) 2025, held December 9–12 in San Antonio, Texas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251208979141/en/ These abstracts showcase the growing clinical utility and innovation of the company’s proprietary RNA platform and underscore REVEAL GENOMICS’ commitment to improving outcomes for individuals with breast cancer. Across all studies, REVEAL GENOMICS and its collaborators analyzed more than 1,300 tumor samples from individuals with HER2-positive, ER-negative, and triple-negative breast cancer—one of the most extensive genomic contributions to SABCS 2025. Seven independent studies validate the performance and clinical impact of REVEAL GENOMICS’ precision oncology platform New HER2
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