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
Microsize and Schedio Group to Acquire Lonza’s Micro-Macinazione Site in Switzerland24.11.2025 16:05:00 EET | Press release
Microsize, a leading CDMO specializing in particle size reduction and control technologies, today announced it has signed an agreement to acquire Micro-Macinazione (Mic Mac), a dedicated micronization facility in Monteggio, Switzerland, from Lonza. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251124545344/en/ The agreement represents Microsize’s second acquisition from Lonza, following the successful 2022 divestment of its Quakertown, Pennsylvania site. In this transaction, Schedio Group – a Swiss-based provider of jet mills, isolators, spray dryers, and engineering services – is investing alongside Microsize to strengthen and localize its operational base in Europe, advancing a shared vision to lead the next generation of integrated particle engineering solutions. With more than 30 years of experience, Mic Mac has served the pharmaceutical industry with proven GMP-compliant jet milling and micronization capabilities for b
Hytera to Debut S1 E at PMRExpo 202524.11.2025 15:17:00 EET | Press release
Hytera, a leading global provider of critical communications technologies and solutions, today introduced the S1 E, a business-ready, palm-sized two-way radio designed specifically for the retail sector, expanding the portfolio of S Series and providing one more option for retail users to choose for their daily operations. The S1 E will make its debut at PMRExpo, the Europe's premier trade fair for secure, mission- and business-critical communication, taking place from November 25th to 27th, 2025, at Koelnmesse in Cologne, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251124768341/en/ Hytera New Released Licence-free Analogue Business Radio S1 E Adhering to the S Series’ signature design language, the S1 E combines a stylish, modern, and minimalist aesthetic with practical functionality. Weighing under 85g, the S1 E provides all-day wearing comfort without tugging or weighing down uniforms. Key enhancements and sta
Merck Takes Patient-Directed Approach to Bring Innovation to the Treatment of Rare Neuromuscular Disorder, Generalized Myasthenia Gravis24.11.2025 15:00:00 EET | Press release
Merck, a leading science and technology company, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for cladribine capsules for the treatment of the rare, chronic autoimmune neuromuscular disorder, generalized Myasthenia Gravis (gMG). In June 2023, the FDA granted Orphan Drug Designation for cladribine capsules for the treatment of gMG. In addition, the Company is actively collaborating with patient organizations and Ad Scientiam, a medical technology company, to support a patient-directed approach to the future management of gMG. If approved, cladribine capsules, currently being studied in the global Phase 3 MyClad trial, could become the first oral treatment for gMG, a rare autoimmune neuromuscular disorder that causes severe muscle weakness and significantly impacts patients’ lives. The FDA’s Fast Track program is designed to facilitate the development and accelerate the review of therapies for serious conditions with unmet medical needs,
BENEFIT and Ant International Partner to Launch Alipay+ in Bahrain to Achieve Global E-Wallet Connectivity24.11.2025 14:04:00 EET | Press release
BENEFIT, the Bahraini innovator and a leading company in fintech and electronic financial transactions service, and Ant International, a leading global digital payment, digitisation and financial technology provider, headquartered in Singapore, have partnered to launch cross-border QR payments between Bahrain’s BENEFIT QR payment scheme and Ant International’s global wallet gateway, Alipay+, during 2026 to support the transition toward a more inclusive digital payments ecosystem. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251124405672/en/ (L-R): Hessa Husain, Deputy Chief Executive - Bahrain Credit Reference Bureau & Data Services at BENEFIT; Abdulwahed AlJanahi, Chief Executive of BENEFIT; Pietro Candela, General Manager of EMEA at Alipay+; and Yousif Al Nefaie, Deputy Chief Executive - Business Development & Services at BENEFIT. By signing a Memorandum of Understanding (MoU), both parties will explore and develop innov
NIQ Joins TikTok Marketing Partners Program Earning Media Mix Modeling Badge24.11.2025 13:00:00 EET | Press release
NIQ, a global leader in consumer intelligence, has earned a partner badge in TikTok’s newly launched Media Mix Modeling (MMM) program – a focus area within TikTok’s Marketing Partners Program. The Marketing Partners Program is composed of carefully selected third-party partners across different categories and specialties who have met TikTok’s rigorous standards for quality and expertise. Badging signals advanced proficiency in media analytics, ensuring state-of-the-art MMM measurement for marketers around the world. As a badged MMM Marketing Partner, NIQ can help advertisers measure the full funnel impact of their marketing campaigns on TikTok and TikTok Shop, enabling them to optimize strategies based on data-driven insights that look beyond last click attribution. As part of the Marketing Partners Program, TikTok’s new reporting API is integrated into NIQ, providing automated TikTok data delivery to NIQ that eliminates error-prone manual processes, accelerates NIQ’s reporting capabil
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