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
Cessna Citation CJ3 Gen3 Achieves First Flight, Advancing Next-Generation Light Jet Toward Certification29.7.2026 19:31:00 EEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE:TXT) company, recently achieved a key milestone as the Cessna Citation CJ3 Gen3 prototype aircraft completed its first flight, advancing the next-generation light jet toward certification. With this milestone, all three next-generation Citation light jets — the CJ4 Gen3, CJ3 Gen3 and M2 Gen3 — have entered flight testing, demonstrating continued momentum across the Cessna next-generation light jet portfolio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260729333762/en/ Cessna Citation CJ3 Gen3 achieves first flight, advancing next-generation light jet toward certification. (Photo credit: Textron Aviation) “This achievement continues the forward momentum of the CJ3 Gen3 program and reflects the discipline, innovation and commitment of this team,” said Chris Hearne, senior vice president, Engineering & Programs. “Comprehensive flight testing will now begin for this aircraft with ri
SES Launches Multi-Orbit Satellite Connectivity on LATAM Airbus, Embraer Fleet29.7.2026 18:30:00 EEST | Press release
SES, a leading space solutions company, was selected by LATAM Airlines to provide multi-orbit inflight connectivity service to its growing fleet of Airbus and Embraer aircraft, solidifying SES’s position as the top provider of multi-orbit broadband service in the Americas and around the world. “LATAM’s passengers will soon benefit from reliable, multi-orbit satellite connectivity that will provide the same fast and dependable internet access they enjoy at home no matter where or when they fly. SES’s partnerships with airlines like LATAM highlight how carriers throughout the Americas are leading the way when it comes to the most advanced connectivity. SES is a trusted partner that powers inflight connectivity,” said Mike DeMarco, SES President of Mobility. More than 60 Airbus (A320NEO and A321XLR) and Embraer aircraft (E195-E2) will be equipped with SES services in the coming years. LATAM will be the largest airline in the region to offer service using SES’s new electronically steered a
Carta Rearchitects Private Capital Operations with Plugins for Claude29.7.2026 17:01:00 EEST | Press release
Carta, the connected platform and AI-native ecosystem for private capital, today announces broad availability of its suite of Plugins for Claude following the initial launch in April 2026. With more than 1,500 companies and firms already using the plugins, Carta is changing the way private capital teams — from founders to CFOs — fundamentally operate, bringing fund administration, cap table management, and dealflow analytics directly into the spreadsheets, presentations, and workflows they already use every day. "For the last decade, private capital operation teams have been held back by a hidden tax: the constant, manual handoff of data between disconnected systems," said Henry Ward, Carta CEO. "Carta is eliminating that broken loop entirely by embedding intelligence directly into the tools teams already use. We are not waiting for an AI-native future for private capital — it is running on Carta today." Carta didn't just give Claude a pipe to its data. Carta built its private-capital
VDyne Announces First Patient Treated in TRIVITA US IDE Pivotal Study of the TriNova™ Transcatheter Tricuspid Valve Replacement System29.7.2026 16:00:00 EEST | Press release
VDyne Inc. (“VDyne”), a privately held medical device company developing an innovative transcatheter tricuspid valve replacement (TTVR) system, today announced that the first patient has been enrolled and treated in the TRIVITA US IDE pivotal study of the TriNova™ system. The randomized controlled study will compare TriNova head-to-head with the commercially available Edwards EVOQUE™ TTVR system. The TRIVITA trial (NCT07516444) initiation marks a significant milestone in advancing treatment for tricuspid regurgitation (TR). The prospective, global, multicenter, randomized (1:1) controlled study is designed to evaluate the safety and effectiveness of the TriNova TTVR system in patients with severe or greater tricuspid regurgitation who are suitable for valve replacement. The study will be conducted in the US and Europe with up to 70 sites participating. The first patient was enrolled at the Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, and tre
Grid Dynamics Accelerates Enterprise AI-Native Transformation With Workforce Certification and GAIN Platforms Rollout29.7.2026 16:00:00 EEST | Press release
Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a leading provider of technology consulting, platform and product engineering, and AI-driven digital transformation services, today announced significant momentum in the adoption of its enterprise agentic AI solutions. Organizations across retail, financial services, manufacturing, CPG, and logistics industries are increasingly deploying Grid Dynamics’ agentic AI-native platforms and Forward Deployed Engineering (FDE)-led services to accelerate software delivery, improve operational efficiency, and transform business processes at scale. Grid Dynamics is widely recognized for its enterprise AI expertise and delivery capabilities across Fortune 1000 organizations. Grid Dynamics has partnership agreements with Anthropic and OpenAI to accelerate the adoption of these platforms within enterprises. By the end of October 2026, Grid Dynamics plans to have 90% of its engineers trained and certified on these platforms. Built to suppo
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