Real World Data Being Presented at EULAR 2017 Demonstrate Acceptance & Confirm Sustainability of Effectiveness, Safety & Adhe...
June 14 2017 - 9:30AM
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
About BENEPALI®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
About BiogenThrough 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 HarborThis 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.
References
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.
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BIOGEN EU MEDIA CONTACT:Benjamin Russell, +41 41 392 19
22publicaffairs.EU@biogen.comorBIOGEN INVESTOR CONTACT:Mike Hencke,
+1-781-464-2442IR@biogen.com
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