IMRALDI®, Biogen’s Adalimumab Biosimilar Referencing Humira®, is Approved in the European Union
The European Commission (EC) granted a marketing authorization for IMRALDI® (also known as SB5), an adalimumab biosimilar referencing Humira®.1
IMRALDI has been developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen (NASDAQ, BIIB) and is approved for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis.
IMRALDI is the third anti-TNF biosimilar from Biogen to receive a marketing authorization in the European Union (EU) following the approval in 2016 of BENEPALI® (etanercept), a biosimilar referencing Enbrel®,2 and FLIXABI® (infliximab), a biosimilar referencing Remicade®.3 Anti-TNF therapies represent some of the EU’s largest drug expenditures, costing an estimated $9 billion (€8 billion) each year from 2011 to 2014.4,5 Introducing biosimilars of the top three anti-TNF therapies in Europe could lead to estimated potential savings of up to $11.44 billion (€9.69 billion), between the patent expiry date of each reference product and 2020.5,6 With the approval of IMRALDI, Biogen has become the first company to have approved biosimilars for all three of these therapies.
“Today’s decision marks another positive step in transforming the lives of people with chronic autoimmune conditions,” said Jean-Paul Kress, EVP International and Head of Global Therapeutic Operations, Biogen. “As the number of approved biosimilars continues to grow, so does the anticipated potential to increase physician choice and patient access to biologics.”
The EC approval was based on a robust preclinical and clinical data package comparing IMRALDI with Humira. The clinical data include results from two head-to-head studies – a Phase I study in healthy volunteers that demonstrated pharmacokinetic bioequivalence to Humira7 and a 52 week Phase III, randomized, double-blind, multicenter study, in which IMRALDI demonstrated comparable efficacy and comparable safety and immunogenicity to Humira in patients with moderate to severe RA despite methotrexate therapy.8,9 The primary endpoint of the Phase III study, the American College of Rheumatology 20% (ACR20) response at Week 24, was met, demonstrating equivalent efficacy to Humira (ACR20 response rate was 72.5% in the IMRALDI group versus 72.0% in the Humira group).8 Between Week 24 and Week 52, in 125 patients who were switched from Humira to IMRALDI, efficacy, safety, and immunogenicity profiles were found to be comparable to those in patients who remained on Humira (129) or IMRALDI (254) during the transition period.9
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
Biogen Safe Harbor
This press release includes forward-looking statements, including statements about the indications from approval and anticipated access to IMRALDI in the EU, and the potential cost savings from the availability of IMRALDI and other biosimilar anti-TNF therapies in the EU. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may," "plan," "will," and other words and terms of similar meaning. You should not place undue reliance on these statements. Drug development and commercialization is a lengthy and complex process, which involves a high degree of risk. Factors that could cause actual results to differ materially from our current expectations include: the risk that unexpected concerns may arise from additional data or analysis, or regulatory authorities may require additional data or information or further studies, or may fail to approve, or refuse to approve, or may delay approval of our biosimilar drug candidates; 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 which could prevent the commercial launch of a product or delay it for many years; and the risks of other unexpected hurdles. For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. These statements are based on our current beliefs and expectations, and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.
1 Humira® is a registered trademark of AbbVie
2 Enbrel® is a registered trademark of Wyeth LLC.
3 Remicade® is a registered trademark of Janssen Biotech, Inc.
4 Extrapolated from global sales from Global Data PMLive Top 50 report, available at: http://www.pmlive.com/top_pharma_list/Top_50_pharmaceutical_products_by_global_sales. Accessed August 2017
5 Currency exchange rates (rounded). Available at: www.xe.com. Accessed August 2017.
6 Psachoulia E, et al. Potential impact of the biosimilars introduction of 3 anti-TNFs in the European market. Value Health 2017;20(5);A143.
7 Shin D, et al. A Phase I Pharmacokinetic Study Comparing SB5, An Adalimumab Biosimilar, And Adalimumab Reference Product (Humira®) in Healthy Subjects. Ann Rheum Dis 2015;74 (suppl 2):1265.
8 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).
9 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.
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Sunny Optics Officially Licenses ImmerVision Panomorph Lens Technology for Global Production13.12.2017 12:47 | Pressemelding
ImmerVision, developer of exclusive and patented panomorph wide-angle imaging technology, is proud to announce that Sunny Optics (Zhongshan) Co., a subsidiary of Sunny Optical Technology (Group) Co. Ltd., a leading manufacturer of integrated optical components and products, has licensed panomorph lens technology for global production, and will deliver its first small form-factor panomorph high-resolution super-wide-angle lenses for smartphones and mobile devices in Q1 2018. Panomorph lens technology combines state-of-the-art optical design and advanced, optimized algorithms, including low-power dewarping, to produce high-resolution super-wide-angle images without distortion, even in low light conditions. Sunny Optical is the largest Chinese lens supplier for the most popular smartphone brands and OEM applications such as sports cameras, surveillance, 360 image capture, autom
Synacor Launches Enhancements to Zimbra Communications and Collaboration Suite13.12.2017 12:30 | Pressemelding
Synacor Inc. (NASDAQ:SYNC) today announced the commercial launch of Zimbra 8.8. The easy-to-use collaboration platform comes with new user experience features such as Zimbra Drive for enterprise-level file sync and sharing and Zimbra Chat. The Network Edition features tech stack enhancements including real-time backup, ActiveSync across mobile and desktop, hierarchical storage management (HSM) that enables customers to move archival data to less expensive storage solutions, and improved delegated admin functionality. “Zimbra 8.8 is an exciting update for end users and technical decision makers,” said Marcus Teo, Vice President, Enterprise Sales & Marketing, Synacor. “Customers look to Zimbra for security, privacy and transparency through open code, extensibility, accessibility on multiple devices and deployment flexibility. This update builds on these tenets and incorporates enhancemen
GSMA Urges Members of the World Trade Organization to Prioritise and Accelerate Investment in Digital Future13.12.2017 12:00 | Pressemelding
On the occasion of the 11th World Trade Organization (WTO) Ministerial Conference, GSMA Director General Mats Granryd called on government leaders to reform their regulatory frameworks in order to encourage a new wave of innovation and investment in digital infrastructure and services. Currently, 108 of the WTO's 164 members have made commitments to facilitate trade in telecoms services, such as the right to establish new telecoms companies, make foreign direct investment in existing companies and enable the cross-border transmission of telecoms services. “Today, more than 5.1 billion people – about two-thirds of the world’s population – subscribe to mobile services. With this broad reach, the mobile industry is a major driver in the global economy, expected to employ nearly 31 million people worldwide and contribute $4.2 trillion in economic value (4.9 per cent of GDP) in 2020,” said
DCS Telecom Selects LeoSat for Innovative Data Solution13.12.2017 10:03 | Pressemelding
LeoSat Enterprises, which is launching a constellation of up to 108 low-earth-orbit communications satellites, has entered into an agreement with DCS Telecom, a leading telecoms provider of satellite and networking solutions in the Middle East, Africa and Asia. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171213005443/en/ DCS Telecom Selects LeoSat for Innovative Data Solution (Photo: Business Wire) DCS Telecom will use LeoSat to upgrade its existing satellite solutions, giving customers access to a unique low-latency network which is expected to revolutionize data connectivity. LeoSat’s system of low earth orbit communications satellites can achieve lower latency and stronger end-to-end security compared to traditional satellite and terrestrial solutions used today. This is achieved through an adv
Andersen Global Expands Presence in Germany with Addition of Thierhoff Müller & Partner13.12.2017 08:01 | Pressemelding
Andersen Global is proud to announce an expanded presence in Germany as Thierhoff Müller & Partner, a tax and legal firm with offices in Leipzig and Frankfurt, combines its practice with Andersen Tax & Legal in Germany. Through its German member firms, Andersen Tax & Legal and Alegis Steuerberatungsgesellschaft mbH, Andersen Global now has more than 65 professionals focused on providing tax and legal services and business advice across five locations in Germany, including Cologne, Dusseldorf, and Merzig. “Thierhoff Müller is highly regarded in complex restructuring matters. Together with our existing legal and tax practice, we will be able to increase our service offerings for our clients,” said Stefan Kraus, Managing Partner of Andersen Tax & Legal in Germany. “We are dedicated to providing outstanding service and are adding additional competencies in tax and legal such as corporate r
Aprecia Pharmaceuticals and Cycle Pharmaceuticals Partner to Develop 3D-Printed Orphan Drugs13.12.2017 08:00 | Pressemelding
Aprecia Pharmaceuticals, LLC (“Aprecia”), The 3DP Pharmaceutical Company, and Cycle Pharmaceuticals, Ltd. (“Cycle”) today announced they have signed a partnership agreement to develop and commercialize orphan drugs using three-dimensionally printed (“3DP”) technology. The planned products will deliver quality-of-life improvements versus existing, approved orphan drugs, and will achieve this by utilizing Aprecia’s proprietary 3DP ZipDose® Technology platform. ZipDose® is the only three-dimensional printing technology used in a pharmaceutical drug product approved by the U.S. Food and Drug Administration. Antonio Benedetti, CEO of Cycle commented: “Many rare disease patients do not have a treatment option at all. For those rare diseases where there is an approved pharmaceutical treatment, patients continue to be burdened by sub-optimal drug formulations. Aprecia’s
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom