Biogen Inc. (Nasdaq: BIIB) today announced that it will present new
data at the European Congress of Rheumatology (EULAR) 2019 in
Madrid, Spain (June 12-15). The abstracts include real-world data
from the company’s biosimilar anti-TNF portfolio, which includes
BENEPALI™ (etanercept), FLIXABI™ (infliximab) and IMRALDI™
(adalimumab). Biosimilars are products that are demonstrated to be
similar to or interchangeable with approved biological product and
have the potential to lower drug costs. In Europe, approximately
145,000 patients have been treated with a Biogen biosimilar and the
company expects the uptake of these products to generate 1.8
billion euros in healthcare cost savings in 2019.
“These new real-world data reinforce Biogen’s ongoing commitment
to providing innovative and value-based therapeutic options to tens
of thousands of patients with unmet medical need,” said Ian
Henshaw, vice president and head of Biogen’s global biosimilars
unit. “The cost savings we generate through our biosimilars
business unit will help alleviate global healthcare system burden,
which could enable governments to allow broader access to critical
therapies.”
To compile real-world evidence, physicians ask patients
open-ended questions about treatment experience. The real-world
data to be presented at EULAR this year provide further insight
into patient experience with anti-TNF biosimilars, including
adherence data.
“Patients with chronic inflammatory diseases face the reality of
a lifetime of ongoing disease management and now biosimilars enable
more patients access to those life-changing medicines while
providing our healthcare systems significant savings,” said Dr.
Peter Taylor, Norman Collisson professor of musculoskeletal
sciences, Nuffield department of orthopedics, rheumatology and
musculoskeletal sciences at the University of Oxford, England. “The
new real-world data to be presented at EULAR further establish the
comparable safety and efficacy of biosimilars against their
reference products.”
Biosimilars represent an important component of Biogen’s
European portfolio. Biosimilar products benefit patients and are
strategically important as Biogen works with payers and health
systems globally with the goal of creating room in healthcare
budgets to provide access for patients to innovative therapies.
Biogen and its collaboration partner Samsung Bioepis will
present a total of nine abstracts at the congress. In February 2012
Biogen entered into a joint venture agreement with Samsung
BioLogics, establishing an entity, Samsung Bioepis, to develop,
manufacture and market biosimilar products.
Data to be presented include results of the real-world data
generating BENEFIT study, which evaluated the outcomes of
transition from the reference product etanercept to its biosimilar
in routine clinical practice. The study demonstrated no clinically
significant difference in disease score from baseline to six months
post transition in 533 patients suffering from rheumatoid arthritis
(RA) and axial spondyloarthritis (axSpA)2 (June 14, 11:45.-13:30
CET – FRI0103 – Hall 10).
Additionally, data from a pooled analysis of etanercept,
infliximab and adalimumab biosimilars and reference products across
1,461 patients will be presented. The analysis demonstrated similar
outcomes between biosimilars and their respective reference
products in terms of disease fluctuation at six months and one year
of treatment3 (June 15, 10:30-12:00 CET – SAT0162 – Hall 10).
Further abstracts evaluating the efficacy, safety and retention
rates of anti-TNF biosimilars in rheumatology include4:
- [OPO236] Glintborg et al. ARTIS: Similar
one-year treatment retention of originator and biosimilar
etanercept. Results of a Nordic collaboration including 1,015
patients with spondyloarthritis (June 14, 10:15-11:45 CET – Hall
7A).
- [SAT0134] Baganz et al. RABBIT: Comparing
real-world retention rates in a matched cohort of rheumatoid
arthritis patients who either remained on the etanercept originator
or switched to a biosimilar (June 15, 10:30-12:00 CET – Hall
10).
- [SAT0146] Haugeberg et al. Drug survival for
biosimilar SB4 etanercept in rheumatoid arthritis both etanercept
naïve and non-medical switch patients with etanercept reference
drug in a Norwegian out-patient clinic. Preliminary results from a
multi-center study (June 15, 10:30-12:00 CET – Hall 10).
- [FRI0094] Haugeberg et al. Long-term drug
survival for biosimilar SB4 etanercept in RA, PsA and aSpA patients
with a non-medical switch from etanercept reference drug (June 14,
11:45-13:30 CET – Hall 10).
- FRI0101] Kiltz et al. Non-medical switching
from originator to biosimilar etanercept - no evidence for a
relevant nocebo effect – a retrospective analysis of real-life
data. (June 14, 11:45-13:30 CET – Hall 10).
- [SAT0141] Rebecca Davies et al. BSRBR:
Frequency and reasons for switching back to biologic originator
following initial switch to biologic biosimilar (June 15,
10:30-12:00 CET– Hall 10).
- [ABSTRACT ONLY] Ruiz-Argüello et al.
Validation of a therapeutic drug monitoring test to measure the
adalimumab biosimilar SB5 in comparison to the reference adalimumab
(ENCORE).
About BENEPALI™ (etanercept)BENEPALI™
(etanercept), a biosimilar referencing Enbrel®5, was approved by
the European Commission (EC) in January 2016 for the treatment of
adults with moderate to severe rheumatoid arthritis, psoriatic
arthritis, axial spondyloarthritis (ankylosing spondylitis and
non-radiographic axial spondyloarthritis) and plaque psoriasis.
BENEPALI™ is currently available in 25 countries in Europe and is
the most prescribed etanercept in the five largest European
countries (Germany, UK, France, Italy and Spain).6
About FLIXABI™ (infliximab)FLIXABI™
(infliximab), a biosimilar referencing Remicade®7, was approved by
the European Commission (EC) in May 2016 for the treatment of
adults with rheumatoid arthritis, Crohn’s disease, ulcerative
colitis, ankylosing spondylitis, psoriatic arthritis or psoriasis.
FLIXABI™ can also be used in patients 6-17 years old with severe,
active Crohn’s disease or severely active ulcerative colitis when
they have not responded to or cannot take other medicines or
treatments. FLIXABI™ is currently available in 17 countries in
Europe.8
About IMRALDI™ (adalimumab)IMRALDI™
(adalimumab), a biosimilar referencing Humira®9, was approved by
the European Commission (EC) in August 2017 for the treatment of
rheumatoid arthritis, 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 currently available in 18 countries in Europe and is the
leading adalimumab biosimilar in Germany and in Europe.10,11
About BiogenAt 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 as well as
related therapeutic adjacencies. 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 (MS), has
introduced the first approved treatment for spinal muscular atrophy
and is focused on advancing neuroscience research programs in MS
and neuroimmunology, Alzheimer’s disease and dementia, movement
disorders, neuromuscular disorders, acute neurology, neurocognitive
disorders, pain and ophthalmology. Biogen also 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 – Twitter,
LinkedIn, Facebook, YouTube.
Biogen Safe HarborThis news
release contains forward-looking statements, including statements
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995, relating to the results
of certain real-world data; the potential benefits, safety and
efficacy of BENEPALI, FLIXABI and IMRALDI; risks and uncertainties
associated with drug development and commercialization; the
potential of Biogen’s commercial business and pipeline programs,
including BENEPALI, FLIXABI and IMRALDI; anticipated benefits and
potential of investments, collaborations and business development
activities; Biogen’s strategy and plans; potential cost healthcare
savings related to biosimilars. These statements may be identified
by words such as “aim,” “anticipate,” “believe,” “could,”
“estimate,” “expect,” “forecast,” “intend,” “may,” “plan,”
“potential,” “possible,” “will,” “would” 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 without limitation the occurrence of
adverse safety events and/or unexpected concerns that may arise
from additional information or further studies; risks of unexpected
costs or delays; 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 Biogen’s biosimilar
drug candidates; risks related to Biogen’s dependence on third
parties for the development and commercialization of biosimilars;
unexpected concerns may arise from additional data, analysis or
results obtained during clinical trials; risks of legal actions,
regulatory scrutiny or other challenges to biosimilars; the risks
of other unexpected hurdles; failure to protect and enforce
Biogen’s data, intellectual property and other proprietary rights
and uncertainties relating to intellectual property claims and
challenges; 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 U.S. Securities and
Exchange Commission. These statements are based on Biogen’s current
beliefs and expectations and speak only as of the date of this news
release. Biogen does not undertake any obligation to publicly
update any forward-looking statements, whether as result of new
information, future developments or otherwise.
Contact:
BIOGEN GLOBAL MEDIA CONTACT:David CAOUETTE+1 617 679
4945public.affairs@biogen.com
BIOGEN EU MEDIA CONTACT: Marc BURI+41 79 944
9064marc.buri@biogen.com BIOGEN INVESTOR CONTACT:Mike HENCKE+1 781
464 2442IR@biogen.com
References:1. Biogen data on file.2. Kruger et
al. BENEFIT Study: A Pan-European Observational Study to Evaluate
Real-world Effectiveness of SB4 Following Transition from
Originator Etanercept (ETN) in Patients with Rheumatoid Arthritis
(RA) or Axial Spondyloarthritis (AxSpA). EULAR 2019. 3. Smolen et
al. A pooled analysis of 1-year clinical outcome by 6-month disease
activity from three TNF inhibitor biosimilar studies in patients
with rheumatoid arthritis. EULAR 2019.4. Data from Biogen- and
Samsung Bioepis- supported studies.5. Enbrel® is a registered
trademark of Wyeth LLC.6. Data on File: IQVIA, GERS, Insight Health
ODV7. Remicade® is a registered trademark of Janssen Biotech,
Inc.8. Data on File: IQVIA, GERS, Insight Health ODV9. Humira® is a
registered trademark of AbbVie Biotechnology Ltd.10. Data on File:
IQVIA, GERS, Insight Health ODV11. Data on File: Biogen, Inc. Q1
First Quarter 2019 Financial Results and Business Update. April
24th, 2019.
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