Business Wire

Biogen and Samsung Bioepis Announce European Launch of IMRALDI™(adalimumab), Solidifying Leadership in European Anti-TNF Market

17.10.2018 09:18:00 EEST | Business Wire | Press release

Share

Biogen (Nasdaq:BIIB) and Samsung Bioepis Co., Ltd. today announced the European launch of IMRALDI™ (adalimumab), a biosimilar referencing HUMIRA®. Starting today, IMRALDI™ will begin launching in major markets across Europe.

The launch of IMRALDI™ marks a significant milestone for Biogen and Samsung Bioepis, as the adalimumab product is the third anti-TNF biosimilar developed by Samsung Bioepis to be commercialized by Biogen across Europe. BENEPALI™ (etanercept) and FLIXABI™ (infliximab) were approved in 2016, and have approximately 100,000 patients currently under treatment with more than 6 million doses administered across 25 and 14 countries, respectively.ii

“We look forward to increasing patient access to this important medicine by leveraging our industry-leading position in the European anti-TNF market,” said Ian Henshaw, Head of Biogen’s Biosimilars Unit.

“The launch of IMRALDI marks what we believe to be a landmark moment for Biogen and Samsung Bioepis and for European healthcare systems. We hope IMRALDI will play an important role widening choice and increasing competition in one of the most high-value areas of the biopharmaceuticals market,” said Sang-Jin Pak, Chief Operating Officer, Samsung Bioepis. “In just six years, Samsung Bioepis has successfully developed the industry’s leading portfolio of anti-TNF biosimilars with a strong pipeline of further biosimilar candidates currently under development.”

“We are proud of our collaboration with Biogen, which brings together the development expertise of Samsung Bioepis with the commercial excellence of Biogen for the benefit of patients across Europe.”

The European Commission (EC) approved IMRALDI™ in August 2017 for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and uveitis.iii

The EC approval was based on data derived from a randomized, double-blind 52-week Phase 3 study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy were randomized to receive either SB5 or the adalimumab reference product (ADL). At Week 24, the ACR20 response rate was 72.4% in the SB5 group versus 72.2% in the ADL group. The safety profile of SB5 was comparable to ADL up to Week 24. At Week 24, 254 patients receiving ADL were re-randomized in a 1:1 ratio to continue on ADL or transitioned to SB5, and 254 patients receiving SB5 continued to receive SB5. Up to Week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by alternating subjects between treatments.iv v


About Biogen
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics.

We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – TwitterLinkedInFacebookYouTube.

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 and ophthalmology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.

Biogen Safe Harbor
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential benefits, safety and efficacy of IMRALDI; the results of certain Phase 3 studies of IMRALDI; the potential of Biogen’s commercial business, including IMRALDI, BENEPALI and FLIXABI; risks and uncertainties associated with drug development and commercialization, including the commercialization of IMRALDI; and market acceptance of biosimilars and related healthcare system matters. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty of success in commercialization of IMRALDI, which may be impacted by, among other things, the level of preparedness of healthcare providers to treat patients, difficulties in obtaining or changes in the availability of reimbursement for IMRALDI, the effectiveness of sales and marketing efforts and problems with the manufacturing process for IMRALDI; risks related to our dependence on third parties for the development and commercialization of biosimilars; risks of legal actions, regulatory scrutiny or other challenges to biosimilars, including IMRALDI; the occurrence of adverse safety events; failure to obtain regulatory approvals in other jurisdictions; failure to protect intellectual property and other proprietary rights; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this press release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments, or otherwise.

# # #

i Humira® is a registered trademark of AbbVie Biotechnology Ltd.
ii Biogen data on file – ex-factory sales
iii https://www.ema.europa.eu/medicines/human/EPAR/imraldi
iv Weinblatt M, et al. FRI0161 Sustained Efficacy and Comparable Safety and Immunogenicity after Transition To SB5 (An Adalimumab Biosimilar) vs Continuation of The Adalimumab Reference Product in Patients with Rheumatoid Arthritis: Result of Phase III Study. Annals of the Rheumatic Diseases 2016;75:487.
v Weinblatt M, et al. A Phase III, Randomized, Double-Blind Clinical Study, Comparing SB5, An Adalimumab Biosimilar, with Adalimumab Reference Product (Humira®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-week results) [abstract]. Arthritis Rheumatol 2015;67 (suppl 10).

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

BIOGEN MEDIA CONTACT:
David Caouette
+1 617 679 4945
david.caouette@biogen.com
or
SAMSUNG BIOEPIS MEDIA CONTACT:
Mingi Hyun
+82-31-8061-1594
mingi.hyun@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

Rimini Street Announces Fiscal Second Quarter 2026 Financial and Operating Results30.7.2026 23:03:00 EEST | Press release

Rimini Street, Inc., (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, managed services and Agentic AI ERP innovation solutions, and the leading third-party support provider for Oracle, SAP and VMware software, today announced results for the fiscal second quarter ended June 30, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730702735/en/ Rimini Street Announces Fiscal Second Quarter 2026 Financial and Operating Results “Second-quarter results and four consecutive quarters of improved growth metrics demonstrate strong demand for our core Rimini Support™ offering, increasing adoption of our broader enterprise software services portfolio and improving sales execution,” said Seth Ravin, president and CEO, Rimini Street. “Real innovation is not about installing a software vendor’s next ‘.ai’ release — it is about reducing total operating costs, improving profitability and enhancing competitive

Rimini Street Launches Rimini Govern™ for AI to Deliver Comprehensive AI Agent Governance, Security & Interoperability as a Service30.7.2026 23:01:00 EEST | Press release

Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced the immediate availability of Rimini Govern™ for AI, the newest offering in the company’s Rimini Govern portfolio of Governance, Risk and Compliance (GRC) solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730389723/en/ Rimini Street Launches Rimini Govern™ for AI to Deliver Comprehensive AI Agent Governance, Security & Interoperability as a Service The new managed service is delivered 24/7/365 through Rimini Street’s Global Command Centers by expert AI engineers to help organizations: Accelerate AI agent deployment Reduce AI agent operational risk Increase visibility into AI agent activity Provide AI agent activity audit capability Control AI agent operating costs Measure business value from AI agent investments Scale AI agent adoptio

One Biosciences Announces Data Validating New Method for Single-Cell Transcriptomic Tumor Profiling from Clinical Pathology Samples30.7.2026 22:03:00 EEST | Press release

One Biosciences, a techbio company pioneering clinical-grade single-cell tumor profiling, today announced data establishing that single-cell RNA expression profiles can be generated from the standard, formalin-fixed paraffin-embedded (FFPE) pathology specimens obtained in routine cancer care using the company’s proprietary platform, OneMap™. The study, conducted with collaborators at Centre Léon Bérard, Hôpital Bichat–Claude Bernard, Institut Curie, and Memorial Sloan Kettering Cancer Center, was released as a preprint on BiorXiv. “Every tumor is a unique ecosystem of many different types of cells, some cancerous, some not. Single cell profiling enables us to understand what those cells are, what they’re doing and potentially how that may impact treatment outcomes,” said Helena Yu, MD, thoracic medical oncologist at Memorial Sloan Kettering Cancer Center. “Until now that type of analysis required different types of samples and workflows than we deploy in clinical care. This study shows

Myers Industries Launches European Production of Scepter Military Packaging30.7.2026 19:04:00 EEST | Press release

Myers Industries, Inc. (NYSE: MYE), a leading manufacturer of Products that Protect™, today announced that its Scepter business has launched production of military ammunition containers in Europe through Scepter International Poland sp z o.o. Production began earlier this year at a privately owned contract manufacturing facility in Poland that was selected by Scepter following a rigorous evaluation process. Initial customer shipments commenced in April 2026. Scepter manufactures a growing portfolio of proprietary ammunition containers using advanced resin compounds. Already fielded by military customers across NATO and allied nations, the ammunition containers are now being produced in Europe to better serve regional demand. Scepter's lightweight, reusable polymer packaging replaces traditional wood and metal containers. The result is improved soldier handling; reduced transportation weight and logistics burden; greater fuel efficiency; lower lifecycle costs; and a durable, corrosion-r

ARIS Recognized as a Leader in First Gartner® Magic Quadrant™ for Digital Twin of an Organization Platforms, Believes This Reinforces Need for Trusted Governance and Control of Enterprise AI30.7.2026 19:00:00 EEST | Press release

ARIS, the process context platform enabling enterprise AI deployment, today announced its recognition as a Leader in the inaugural Gartner Magic Quadrant for Digital Twin of An Organization (DTO) Platforms – where it believes agentic AI, autonomous workflows, and enterprise governance converge. As enterprises move from AI experimentation to autonomous agent deployment, a critical challenge emerges: how do you safely scale autonomous AI when the enterprise lacks a unified digital twin – a single source of truth for processes, data, governance, and outcomes? Gartner describes the DTO as a dynamic software model that relies on operational and contextual data to understand how an organization operationalizes its business model, connects with its current state, responds to changes, deploys resources, simulates future states and delivers customer value. "Enterprises are rightfully ambitious about agentic AI and autonomous workflows," said Guillaume Bacuvier, CEO of ARIS. "But they're discove

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye