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
Edgewater Networks Announces Event Sponsorship of BroadSoft Connections 201720.10.2017 21:00 | Pressemelding
Edgewater Networks, Inc., the industry leader in Network Edge Orchestration, announced today that it is an event sponsor of the BroadSoft Connections 2017 user conference, which takes place October 22-25 at the JW Marriott Phoenix Desert Ridge Resort & Spa in Phoenix, AZ. During the event, Edgewater Networks will feature demonstrations of the latest end-to-end network interoperability capabilities, including Zero Touch Provisioning, UC Analytics from the core to the endpoint, SD-WAN optimized for BroadSoft, and much more. Continuing a long-standing partnership with BroadSoft, Edgewater Networks has completed another level of BroadCloud certification, this time for local survivability which is critical for business continuity for SMB and Enterprise customers. BroadSoft’s PacketSmart is available on all EdgeMarc Intelligent Edges. All elements of the Network Edge Orchestration are
More than 70 Companies to Showcase Top Tech at CES Unveiled Paris20.10.2017 15:08 | Pressemelding
The Consumer Technology Association (CTA) today announced that more than 70 exhibitors will showcase their latest innovations at the now sold-out fifth annual CES Unveiled Paris The event will focus on the Internet of Things (IoT), connectivity and smart cities, and draw more than 600 attendees. CES Unveiled Paris will run from 2-7:30 PM on Tuesday, October 24, 2017 at the Palais Brongniart. Regional technology companies, top-tier media outlets, buyers and key industry influencers will come together at CES Unveiled Paris to get a direct look at the latest industry developments. The day kicks off with a CES news conference and CTA market trends presentation. Conference programming is followed by a tabletop exhibition & networking reception. Curated exhibitors will be there to showcase top tech from robotics and audio to smart home and augmented and virtual reality. Notable
Westinghouse Receives Regulatory Approval for Analysis Methodologies20.10.2017 12:15 | Pressemelding
Westinghouse Electric Company today announced that it has received approval from the U.S. Nuclear Regulatory Commission (NRC) for two new important analysis methodologies that will be used to upgrade Westinghouse- and Combustion Engineering-based nuclear steam supply system (NSSS) safety analyses. The approvals granted are for the new FULL SPECTRUMTM Loss of Coolant Accident (FSLOCATM) methodology and the Performance Analysis and Design Model software code update, PAD5. FSLOCA is capable of improved modeling of the transient response in a pressurized water reactor to the full spectrum of LOCA break sizes that could occur, and PAD5 is the next generation of the Westinghouse fuel rod design performance code. “These codes were developed to work in concert with each other to maximize analytical margin for nuclear utilities,” said Michele DeWitt, senior vice preside
Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®20.10.2017 12:03 | Pressemelding
Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C. Positive results from studies of Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22. In addition, updated results f
Schlumberger Announces Third-Quarter 2017 Results20.10.2017 11:00 | Pressemelding
Schlumberger Limited (NYSE:SLB) today reported results for the third quarter of 2017. (Stated in millions, except per share amounts) Three Months Ended Change Sept. 30, 2017 Jun. 30, 2017 Sept. 30, 2016 Sequential Year-on-year
SP3H Announces That It Has Obtained a €1.2 Million European Union Grant for Its Intelligent and Clean Vehicle (VIP) Project20.10.2017 10:47 | Pressemelding
SP3H is proud to announce joining the very select circle of the 10 French winners of the H2020 SME Instrument Phase 2 program since 2014. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171020005325/en/ Last summer VIP received the very prestigious SME instrument phase 2 H2020 label in the "transport & smart cities mobility" category. With an overall budget of € 1.7 million, VIP is subsidized by the European Union at a rate of 70% or €1.2 million. The framework contract was officially signed early October. VIP is the pre-industrialization program for Fuelbox sensors, the world's first miniaturized scanner capable of analyzing the quality of fuels on board vehicles. The heart of the program remains closely linked to the reduction of CO2 and pollutant emissions from vehicle
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom