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
bet365 Partners with TestMu AI to Accelerate Global Release Velocity with Agentic AI Quality Engineering31.3.2026 20:01:00 EEST | Press release
TestMu AI (Formerly LambdaTest), the world's first full-stack Agentic AI Quality Engineering platform, today announced that Hillside Technology Limited, the technology powerhouse behind global online gambling leader bet365, has adopted its platform to unify software testing and support hundreds of weekly production releases. The global online gaming industry is currently experiencing a massive shift, with the market projected to exceed $150 billion by 2030. As mobile gaming becomes the primary touchpoint for users, the technical complexity of delivering a seamless, low-latency experience has grown exponentially. For industry giants like bet365, the need to validate software across an infinite matrix of hardware, screen resolutions, and OS versions is a mission-critical requirement. This partnership ensures that, as gaming becomes more mobile-centric, bet365 can lead with technical excellence by testing on real-world configurations that mirror its diverse global user base. Founded in 20
IFF Secures First Heart Health Claim for Soy Protein in Australia and New Zealand31.3.2026 17:00:00 EEST | Press release
IFF (NYSE: IFF), a global leader in flavors, fragrances, food ingredients and health & biosciences announced today that a new heart health claim for isolated soy protein has been accepted by the Food Standards Australia New Zealand (FSANZ). The approval enables food and beverage manufacturers in Australia and New Zealand to link soy protein consumption with healthy blood cholesterol levels. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330523416/en/ First heart health claim approved for soy protein in Australia and New Zealand. “For decades, IFF has invested in the science behind soy protein and its role in supporting cardiovascular health,” said Tony Andrew, vice president of protein solutions for IFF Food Ingredients. “This approved claim validates years of rigorous research and collaboration. With our deep expertise in ingredient science, application and scale, we are well-positioned to help our customers translate th
Andersen Consulting Strengthens Capabilities with Addition of Lukkap31.3.2026 16:30:00 EEST | Press release
Andersen Consulting adds collaborating firm Lukkap, a consultancy focused on experience-driven capabilities aligned with clients’ evolving people, customer, and digital transformation needs. Founded in 2009 and headquartered in Spain, Lukkap delivers integrated solutions that help organizations transform how they serve customers, engage employees, and unlock value through behavioral insights and data analytics. The firm’s multidisciplinary approach spans customer journey redesign, high-impact employee experience programs, talent and leadership development, predictive analytics, and comprehensive outplacement and transition services. Lukkap works across sectors — including healthcare, pharmaceutical, consumer goods, retail, finance, and banking — to build human-centered strategies that drive measurable business results. “By combining our experience-led methodology with Andersen Consulting’s global platform, we can accelerate the way organizations approach customer experience,” said Albe
Sub-Q Bionics Closes $1.5M Pre-Seed Round to Advance Next-Generation Solution for Lymphedema Care31.3.2026 16:26:00 EEST | Press release
Sub-Q Bionics, a medical device company developing next-generation solutions to improve care for patients living with lymphedema, today announced the successful close of its $1.5 million pre-seed funding round. The round includes investment from Mayo Clinic and Yeda, the technology transfer company of the Weizmann Institute of Science, as well as several private investors. The Israel Innovation Authority also provided matching funds. The funding will enable Sub-Q Bionics to continue to develop its novel bionic lymph node technology designed to transform how lymphedema is managed, based on scientific innovations from the Weizmann Institute and Shamir Medical Center. The system aims to provide a solution to manage fluid with a subcutaneous implant that will allow patients freedom of movement, automatic fluid management and reduction of symptoms such as pain and swelling. Lymphedema affects millions of patients worldwide, especially breast cancer survivors, and remains significantly under
HTEC Achieves SOC 2 Type II Attestation, Reinforcing Commitment to Client Trust31.3.2026 16:25:00 EEST | Press release
HTECtoday announced that it has successfully achieved a SOC 2 Type II attestation, audited by Deloitte, demonstrating the company’s commitment to maintaining high standards in security, availability, and confidentiality. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260331132225/en/ HTEC today announced that it has successfully achieved a SOC 2 Type II attestation, audited by Deloitte, demonstrating the company’s commitment to maintaining high standards in security, availability, and confidentiality. For clients, this means working with a technology partner whose practices are standardized, consistently executed, and independently verified over time. It reflects a level of operational maturity where security, reliability, and data protection are built into every engagement. Achieving this standard required coordinated effort across the entire organization. Compliance, engineering, delivery, security, IT, legal, and people t
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