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
HistoSonics Treats First Patients Evaluating the Edison® Histotripsy System for the Treatment of Benign Prostatic Hyperplasia (BPH)30.3.2026 15:00:00 EEST | Press release
HistoSonics, the developer of the Edison® Histotripsy System and novel histotripsy therapy platform, today announced the successful treatments of the first patients in WOLVERINE, a prospective feasibility trial evaluating the Edison® Histotripsy System for the treatment of benign prostatic hyperplasia (BPH) at Prince of Wales Hospital in Hong Kong, a teaching hospital for The Chinese University of Hong Kong. The Edison System is a novel, non-invasive, image guided platform that uses the mechanical properties of focused ultrasound, called histotripsy, to destroy unwanted tissue without the need for invasive procedures, and with potentially fewer side effects than traditional, invasive therapies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330349844/en/ HistoSonics Non-Invasive Edison Histotripsy System. Image credit: HistoSonics WOLVERINE is a prospective, multi-center, single-arm feasibility trial designed to evaluate
Westinghouse Celebrates Record-breaking 80 Years of Nuclear Fuel Manufacture at Springfields30.3.2026 15:00:00 EEST | Press release
The Westinghouse Springfields facility in Lancashire, UK, has marked a significant milestone as the oldest continuous nuclear fuel manufacturing site in the world, starting from its original license on the 28th, March 1946. The site was chosen by the UK Government to develop nuclear fuel for the world’s earliest civil nuclear power stations, as well as subsequent Magnox and Advanced Gas Reactors (AGR) reactors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330135973/en/ From left to right: Sophie Lemaire; Marc Chevrel; Rory O'Neill; Craig Boothby; and Robert Gofton, CEO at Nuclear Institute Across the last eight decades, the Springfields site has supported the UK nuclear fleet, manufacturing more than eight million AGR pins, sintering and pressing over 500 million AGR uranium pellets and 222,000 AGR grids – which is equivalent to burning over 685 tonnes of coal, avoiding the emission of nearly 3 billion tonnes of CO2. Sp
Biocytogen Grants Taisho Pharmaceutical a License to its RenNano ® Fully Human Heavy Chain-Only Antibody Discovery Platform30.3.2026 14:00:00 EEST | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that it has entered into a platform license agreement with Taisho Pharmaceutical Co., Ltd. (“Taisho”), granting Taisho the right to access and use Biocytogen’s proprietary RenNano® fully human heavy chain-only antibody (HCAbs) discovery platform for its internal research and development programs. Under the terms of the agreement, Taisho will leverage RenNano® mice to enable the generation and screening of fully human HCAbs in vivo and to support downstream research associated with antibody discovery. Financial terms of the agreement have not been disclosed. “We are very pleased to enter into this collaboration with Taisho,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “RenNano® is a robust and powerful fully human VHH discovery platform that pro
Meiji Seika Pharma Invests in Centivax to Develop Next Generation Universal Vaccine Platform30.3.2026 14:00:00 EEST | Press release
Meiji Seika Pharma Co., Ltd. (Head Office: Chuo-ku, Tokyo, President and Representative Director: Toshiaki Nagasato) today announced a strategic investment in Centivax, Inc. (Head Office: South San Francisco, CA, USA), a biotechnology company developing next-generation vaccines and therapies for universal protection against highly diverse targets. Centivax’s lead program includes a universal seasonal influenza vaccine (Centi-Flu 01) currently in a Phase 1 clinical study. Unlike conventional seasonal flu vaccines, which must be manufactured annually based on recommended candidate vaccine viruses, Centivax’s platform focuses both antibody and cellular immune responses on conserved regions of the influenza virus that cannot mutate and are shared across strains and distant subtypes. This approach aims to generate broad, consistent, and durable immunity against both seasonal and pandemic influenza. Meiji’s strategic investment aims to accelerate the advancement of Centi-Flu 01 and further a
Samsung Biologics Strike: Labor Union Warns of CDMO Supply Chain Risks Following Overwhelming Vote30.3.2026 12:52:00 EEST | Press release
The Samsung Biologics Labor Union (President: Jaesung Park), representing approximately 75% of the company's total employees, announced today that its members have overwhelmingly voted in favor of a strike, with 95.52% voting in favor on a 95.38% turnout during a voting period from March 24 to March 29. Following the Incheon Regional Labor Relations Commission's decision to cease mediation, the union has now secured the legal mandate to strike. The union stressed that this strike is not merely a wage dispute. It stems from deep structural concerns regarding the company’s ESG management, lack of operational autonomy, and passive labor relations. Primarily, the union highlighted unresolved corporate governance issues, including allegations concerning unfair labor practices and the unauthorized use of employee personal data, which were prominently reported by South Korea's major broadcaster, MBC, in November 2025. The union believes this crisis stems from management's failure to address r
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