Real World Data Being Presented at EULAR 2017 Demonstrate Acceptance and Confirm Sustainability of Effectiveness, Safety and Adherence among Patients Switching To BENEPALI® (Etanercept Biosimilar of Biogen) from Reference Etanercept
14.6.2017 13:30 | Business Wire
Real world evidence from investigator-initiated studies supported by Biogen (NASDAQ: BIIB), demonstrating sustained efficacy and safety, and high acceptance and adherence in patients initiating treatment with BENEPALI® (etanercept), are being presented at the Annual European Congress of Rheumatology (EULAR) 2017, held 14–17 June in Madrid, Spain.1,2,3 Within the EU, approximately 50,000 patients are currently being treated with anti-TNF biosimilars from Biogen across 16 countries.4
Two real world studies evaluate the safety and efficacy of BENEPALI® in patients following a switch from reference etanercept. In 1,548 patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (SpA) from the DANBIO registry, disease activity was shown to be largely unaffected at 3 months post-switch and comparable to that observed in the 3 months prior to switch.1 Furthermore, in a separate cohort of 92 patients with RA, PsA or ankylosing spondylitis (AS) in the UK, a low rate of treatment discontinuations due to inefficacy or adverse events was demonstrated at 6 months post-switch.2
Further real world data highlight the acceptance of BENEPALI® and adherence to treatment among patients who were switched from reference etanercept, according to a defined transition protocol. In one UK study of 96 adult patients treated for RA, PsA or AS, 99% agreed to switch.2 91% of the group remained on BENEPALI® at 6 months.2 In another study of 643 patients with rheumatic disease in the Netherlands, 99% (636 patients) agreed to switch to BENEPALI® from reference etanercept. At 3 months, 36 of the 636 patients had discontinued treatment.3 Both studies reflect that treatment with BENEPALI® provides persistency within the expectations of the reference product.2,3
“Biogen continues to make a difference in the lives of patients through our portfolio of anti-TNF biosimilar products, which play an important role in ensuring more people have access to the treatments they need,” said Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen. “Our ongoing efforts to forge partnerships with healthcare organizations and systems have opened doors for biosimilar adoption in a number of European countries, although more can be done to set the right policy environment so that all countries can unlock the full value of these therapies.”
The abstracts being presented at EULAR 2017, showcasing data from Biogen-supported studies, include:
- Thakur K, et al. Etanercept Biosimilar Usage and Associated Cost Savings in Germany [THU0656] – Thursday, June 15, 2017, 1:10pm CEST, Poster Area
- Glintborg B, et al. Clinical Outcomes from a Nationwide Non-Medical Switch from Originator to Biosimilar Etanercept in Patients with Inflammatory Arthritis after 5 Months Follow-Up. Results from the DANBIO Registry [FRI0190] – Friday, June 16, 2017, 1:40pm CEST, Poster Area
- Tweehuysen L, et al. Higher Acceptance and Persistence Rates after Biosimilar Transitioning in Patients with a Rheumatic Disease after Employing an Enhanced Communication Strategy [FRI0200] – Friday, June 16, 2017, 11:45am CEST, Poster Area
- Sigurdardottir V, et al. Switching from Reference Product Etanercept to the Biosimilar SB4 in a Real-Life Setting: Follow-Up of 147 Patients [SAT0173] – Saturday, June 17, 2017, 10:15am CEST, Poster Area
- Holroyd C, et al. Switching from Bio-Original Etanercept to Biosimilar Etanercept SB4: Patient Acceptability and Outcomes in the Real World [AB0377] – Publication Only
BENEPALI is an etanercept biosimilar to the reference product Enbrel®.5 BENEPALI is approved in Europe for the treatment of adults with moderate to severe RA, psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. BENEPALI is currently available in 16 European countries.4
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 potential benefits of our products and programs and expected timing of results from clinical trials. 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; 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.
This medicinal product is subject to additional monitoring.
1 Glintborg B, et al. Clinical outcomes from a nationwide
non-medical switch from originator to biosimilar etanercept in patients
with inflammatory arthritis after 5 months follow-up. Results from the
DANBIO registry. Abstract presented at EULAR 14–17 June 2017, Madrid,
Spain. Abstract #FRI0190.
2 Holroyd C, et al. Switching from bio-original etanercept to biosimilar etanercept SB4: patient acceptability and outcomes in the real world. Abstract presented at EULAR 14–17 June 2017, Madrid, Spain. Abstract #AB0377.
3 Tweehuysen L, et al. Higher Acceptance and Persistence Rates after Biosimilar Transitioning in Patients with a Rheumatic Disease after Employing an Enhanced Communication Strategy. Abstract presented at EULAR 14–17 June 2017, Madrid, Spain. Abstract #FRI0200.
4 Biogen data on file. June 2017.
5 Enbrel® is a registered trademark of Wyeth LLC.
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
IBC’s Big Screen to Explore the Future of Camera and Display Technologies and the Business Behind Cinema22.8.2017 16:58 | Pressemelding
IBC today announced the details of its Big Screen programme, taking place in a specially built auditorium designed to IBC’s specifications and featuring the very latest in cinema technology. With the latest Dolby Vision dramatic imaging and Dolby Atmos immersive audio sound installation, the four-day programme examines and demonstrates the hottest topics, themes, and insights surrounding the art, science, and business of cinema - from capture through to exhibition. As well as being the home of the Big Screen programme, the auditorium will screen in Dolby Vision and Dolby Atmos, Baby Driver, the acclaimed Edgar Wright feature from 2017. The programme for 2017, which has been shaped by a committee of global industry professionals, is an insightful examination of the future of cinema. From virtual reality in cinema to laser and camera assessments, visitors will get up to speed
Digi Communications N.V. Announces the Publishing of an Update to the Investigation by the Romanian National Anti-Corruption Directorate22.8.2017 16:38 | Pressemelding
In connection with the investigation triggered by the Romanian National Anti-Corruption Directorate (“DNA”), which we have previously disclosed to the market and to our investors in the initial public offering prospectus dated 26 April 2017, in the supplemental prospectus dated 8 May 2017 (together, the “Prospectus”), as well as in the subsequent public reports, we inform you that, based on the public release no 832/VIII/3 issued on 22 August 2017, the DNA sent to court under the judiciary control Mr. Ioan Bendei (Vice-president of the Board of Directors of RCS & RDS S.A. – the Company’s subsidiary („RCS&RDS”)) in connection with the offences of bribery and accessory to money laundering, as well as RCS&RDS in connection with the offences of bribery and money laundering, INTEGRASOFT S.R.L. (one of RCS&RDS’s subsidiaries in Romania) in connection with the offence of accessory to mon
SailPoint Named a Leader in Cloud-based Identity Governance22.8.2017 14:00 | Pressemelding
SailPoint, the leader in enterprise identity management, was recently named the overall market leader in KuppingerCole’s 2017 “Leadership Compass: Identity as a Service: Cloud-based Provisioning, Access Governance and Federation.” In addition to being named a leader in every category of the report, SailPoint received superior rankings in four of the five evaluation criteria: security, functionality, interoperability and usability. KuppingerCole is an international and independent analyst organization with a strong focus on Information Security and Identity and Access Management. KuppingerCole’s Leadership Compass reports provide an in-depth analysis of the main players in the market, defining each as a follower, challenger or leader. The Leadership Compass Report for IDaaS evaluates leaders in innovation, product features, and market reach for identity-as-a-service offerings tar
Meggitt Training Systems to Exhibit at DSEI 201722.8.2017 14:00 | Pressemelding
Meggitt Training Systems, the leading provider of integrated live-fire and virtual weapons training products and services for armed forces and law enforcement, will participate at Defence and Security Equipment International (DSEI) through the Georgia Department of Economic Development. The military and security industry event will be held September 12-15, 2017 at ExCeL in London, England. “Today’s threats necessitate maximum realism, despite stretched budgets, and that’s what Meggitt provides to government and commercial customers globally,” said Mark Mears, managing director at Meggitt Training Systems, Ltd. “Although proudly based in Georgia, Meggitt Training Systems is part of Meggitt PLC, a UK-headquartered corporation. As such, we particularly look forward to engaging with current and prospective customers at DSEI, the UK’s largest defense and security trade show.” On
Camelbay Real Estate Management NL B.V. Selects Yardi Voyager22.8.2017 13:58 | Pressemelding
Camelbay Real Estate Management NL B.V. will utilise Yardi Voyager® 7S, a browser-agnostic, fully mobile Software-as-a-Service platform, as its accounting and property management platform. Camelbay will use Yardi Voyager to streamline its property management, leasing and accounting processes for its Dutch real estate portfolio, which is predominantly comprised of commercial office assets. “The automation, transparency and fully integrated accounting and property management that Voyager provides will help us manage our daily financial and operational activities more efficiently and enhance our competitive position within the Dutch office market,” said Alon Levy, Director of Camelbay Real Estate Management NL B.V. “We are very pleased to welcome Camelbay as our latest client in the Netherlands,” said Neal Gemassmer, Vice President of International for Yardi.
Laser Design CyberGage®360, Automated 3D Scanning & Inspection System Adopted by Proto Labs in their State-of-the-Art Metrology Lab22.8.2017 13:44 | Pressemelding
Laser Design, Inc., a subsidiary of CyberOptics (NASDAQ:CYBE), and premier provider of ultra-precise 3D scanning systems and services, announces the adoption of the CyberGage360 3D Scanning and Inspection system by Proto Labs, the world’s fastest digital manufacturing source for custom prototypes and low-volume production parts providing unprecedented speed-to-market value for designers and engineers. “At Proto Labs, we strive to challenge the traditional rules of manufacturing in order to deliver custom manufactured components at unprecedented speeds,” said Dylan Lundberg, Senior Manufacturing Engineer of Protoworks, Proto Labs’ R&D lab. “Everything we do revolves around reducing our customers’ time to market and we do that by digitalizing the entire manufacturing process. From our front-end services to our proprietary processes on the manufacturing floor, you will find thr
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom