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
Incyte Announces the European Commission Approval of Zynyz ® (retifanlimab) for the First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC)6.3.2026 23:42:00 EET | Press release
Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). “The EC approval of Zynyz marks an important step forward for patients with advanced SCAC, a rare cancer for which meaningful treatment advances have not occurred in several decades,” said Bill Meury, President and Chief Executive Officer, Incyte. “As the first PD-1 immunotherapy approved in Europe in combination with platinum-based chemotherapy in the first-line setting, Zynyz helps expand the standard-of-care options available to clinicians and underscores our commitment to delivering innovative medicines that can have an impact for patients.” The EC decision follows the January 2026 positive opinion received from the European Medicines Agency’s Committee f
Dfns Launches Payouts6.3.2026 22:27:00 EET | Press release
Dfns today announced the launch of Payouts, a new API enabling institutions to convert stablecoins to fiat and route payouts across multiple bank accounts while keeping wallet-level governance and controls in place. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305327930/en/ Convert stablecoins to fiat and settle payouts to bank accounts in 94 countries, today. Solving the problem of single-rail off-ramps Today, most fintechs and institutions still hard-wire a single payout provider into their stack, or rely on vertically integrated models that bundle routing, pricing, custody, and settlement together. That approach may be convenient early on, but it creates structural problems at scale: weak price discovery because there is no competitive pressure on margins, limited auditability because routing decisions are opaque, and operational fragility because a single provider degradation in any corridor requires architectural i
Klarna Group Plc Clarifies Mechanics of March 9 Lock-Up Expiration6.3.2026 21:23:00 EET | Press release
Klarna Group plc (NYSE: KLAR) today issues the following clarification to ensure investors and market participants have accurate information regarding the mechanics of its lock-up expiration on March 9, 2026, the processes required before pre-IPO shares can be traded on the NYSE, and the prior liquidity opportunities already available to shareholders. This release contains only factual descriptions of the Company's share structure and applicable processes. It does not constitute guidance or a projection of any kind regarding future trading volumes, share price, or the intentions of any shareholder and speaks only as of the date of this press release. 1. 335 million locked-up shares — but two different categories Of the 378 million total ordinary shares outstanding, approximately 335 million are subject to lock-up restrictions expiring March 9, 2026. However, these shares fall into two distinct categories governed by separate sets of regulations. A. 159 million shares (48% of locked-up
Lone Star Funds Announces Agreement to Acquire the Capsules & Health Ingredients Division of Lonza Group AG6.3.2026 19:30:00 EET | Press release
Lone Star Funds (“Lone Star”) today announced that an affiliate of Lone Star Fund XII, L.P. has entered into a definitive agreement to acquire the Capsules & Health Ingredients (“CHI”) division of Lonza Group AG. As part of the transaction, Lonza will retain a 40% equity position in the business. Headquartered in Basel, Switzerland, CHI operates globally across the Americas, Europe and Asia Pacific. The business comprises three segments: Hard Empty Capsules: leading global manufacturer of gelatin and plant-based capsules offering a broad range of innovative solutions for pharmaceutical and nutraceutical customers. Dosage Form Solutions: end-to-end development and manufacturing platform serving nutraceutical and pharmaceutical customers. Health Ingredients: provider of branded, science-backed nutrition ingredients serving joint health, energy and active lifestyle markets. Lone Star believes CHI is a high-quality, globally recognized platform with strong technical capabilities, different
Sutherland Launches FinAI Hub to Industrialize Agentic AI for Banking and Financial Services6.3.2026 15:00:00 EET | Press release
Today, Sutherland announced the launch of Sutherland FinAI Hub, an enterprise Agentic AI platform built exclusively for Banking and Financial Services. As financial institutions accelerate AI adoption, many initiatives remain confined to pilots, unable to scale across legacy systems and core operations. Sutherland FinAI Hub is designed to help close that gap. FinAI Hub is an innovation ecosystem where Sutherland works with clients to design, prototype, and scale Agentic AI workflows across core operations. At launch, the platform brings together a large and expanding workforce of domain-trained AI agents purpose-built for financial institutions, supporting functions across retail banking, payments, cards, consumer and commercial lending, servicing, back office, risk and compliance functions. These modular agents can operate independently or be orchestrated across end-to-end workflows spanning onboarding, KYC, AML, fraud, underwriting, payments, disputes, servicing, and collections. For
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