Biogen and Samsung Bioepis to Present Data for Infliximab and
Adalimumab Biosimilars at United European Gastroenterology Week
Biogen Inc. (Nasdaq: BIIB) and Samsung Bioepis today announced that
they will present new real-world data from the companies’ anti-TNF
biosimilar portfolio, which includes FLIXABI™ (infliximab) and
IMRALDI™ (adalimumab). These data, which provide further insight
into the long-term safety and efficacy as well as patient
experience with anti-TNF biosimilars, are being presented at United
European Gastroenterology (UEG) Week 2019 taking place in
Barcelona, Spain (October 19-23).
Biosimilars are products that are demonstrated to be highly
similar to reference biological product and have the potential to
lower drug costs. In Europe, approximately 170,000 patients have
been treated with Biogen and Samsung Bioepis’ anti-TNF biosimilars.
Biogen expects the uptake of these products to generate 1.8 billion
euros in healthcare cost savings in 2019.1
“Patients living with severe autoimmune diseases such as IBD are
looking for long-term treatments to safely and effectively control
symptoms and improve their quality of life. Biosimilars now open
the door for more patients to access biologic medicines and
effectively manage their GI diseases,” said Alessandro Armuzzi,
M.D., Ph.D., Head, Inflammatory Bowel Disease Unit Complesso
Integrato Columbus Catholic University of Rome/Italy.
Four Biogen and Samsung Bioepis supported abstracts will
be presented at UEG Week 2019.2
Data to be presented at UEG Week 2019 include a clinical
evaluation of the switch from reference adalimumab to IMRALDI in 87
patients with IBD – either Crohn’s disease or ulcerative colitis.
The study results showed an overall similar performance for the
serum levels of adalimumab between IMRALDI and reference
adalimumab. Moreover, symptom activity indexes and inflammatory
markers remained consistent after switching to IMRALDI.3
[P1806 – October 23 (Wed), 2019, 09:00-14:00 CET,
Poster Exhibition Hall 7]
“We plan to continue to conduct research with the goal of
generating data that will enable us to deliver value to patients
with high unmet needs,” said Ian Henshaw, Vice President and Head
of Biogen’s Global Biosimilars Unit.
An interim analysis of the non-interventional PERFUSE study will
also be presented. This study investigated persistence (the number
of patients continuing on treatment) and immunogenicity of FLIXABI
in three subsets of IBD patients receiving FLIXABI. These interim
results demonstrate high persistence on FLIXABI with no clinical
differences observed (disease scores HBA or Simple Clinical Colitis
Activity Index (SCCAI)) for the patients who transitioned.4
[P1095 – October 22 (Tue), 2019, 09:00-17:00 CET,
Poster Exhibition Hall 7]
“We remain committed to advancing our strong pipeline of
biosimilar candidates, so that more patients and healthcare systems
across the region will be able to benefit from biosimilars,” said
Seongwon Han, M.D., Vice President and Lead of Medical Team,
Samsung Bioepis.
In addition, early results from the IBISS study are reported. In
this real-world cohort of IBD patients transitioning from one
infliximab biosimilar (CT-P13) to another (FLIXABI), showed similar
effectiveness and safety.5 [P0419 - October 21
(Mon), 2019, 10:30-17:00 CET, Poster Exhibition Hall 7]
The fourth abstract to be presented focuses on the
personalization and optimization of therapeutic options.
[P0385 - October 21 (Mon), 2019, 10:30-17:00 CET,
Poster Exhibition Hall 7]
About FLIXABI™
(infliximab)FLIXABI™ (infliximab), a
biosimilar referencing Remicade®6, 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.7
About IMRALDI™
(adalimumab)IMRALDI™ (adalimumab), a
biosimilar referencing Humira®8, was approved by
the European Commission (EC) in August 2017 for the treatment of
rheumatoid arthritis, juvenile idiopathic arthritis, axial
spondylarthritis, psoriatic arthritis, psoriasis, pediatric plaque
psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s
disease, pediatric Crohn’s disease, ulcerative colitis and uveitis,
pediatric uveitis. IMRALDI is currently available in 19 countries
in Europe and is the leading adalimumab biosimilar in six European
countries, such as Germany, Spain, Sweden, Poland, Denmark and
Czech Republic.9,10 There are currently over 50,000 patients in
Europe receiving treatment with IMRALDI.1
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. Today Biogen has the leading
portfolio of medicines to treat multiple sclerosis, has introduced
the first approved treatment for spinal muscular atrophy,
commercializes biosimilars of advanced biologics and is focused on
advancing research programs in multiple sclerosis and
neuroimmunology, neuromuscular disorders, movement disorders,
Alzheimer’s disease and dementia, ophthalmology, immunology,
neurocognitive disorders, acute neurology and pain.
We routinely post information that may be important to investors
on our website at www.biogen.com. 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 FLIXABI and IMRALDI; potential clinical effects of
FLIXABI and IMRALDI; risks and uncertainties associated with drug
development and commercialization; clinical trial results and
plans; the potential of Biogen’s commercial business, including
FLIXABI and IMRALDI; Biogen’s strategy and plans; and potential
cost healthcare savings related to biosimilars. These statements
may be identified by words such as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “goal,” “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; 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.
About Samsung Bioepis Co., Ltd.Established in
2012, Samsung Bioepis is a biopharmaceutical company committed to
realizing healthcare that is accessible to everyone. Through
innovations in product development and a firm commitment to
quality, Samsung Bioepis aims to become the world's leading
biopharmaceutical company. Samsung Bioepis continues to advance a
broad pipeline of biosimilar candidates that cover a spectrum of
therapeutic areas, including immunology, oncology, hematology and
ophthalmology. Samsung Bioepis is a joint venture between Samsung
BioLogics and Biogen.
For more information, please visit: www.samsungbioepis.com and
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References:1. Biogen data on file.2. Data from
Biogen- and Samsung Bioepis- supported studies.3. Lukas et al.
Impact of the Switch from Original Adalimumab to Biosimilar
Adalimumab SB5 on Serum Drug Trough Levels and Clinical and
Biological Disease Activity in Patients with IBD. UEG Week 2019.4.
Bouhnik et al. PERFUSE: a French Prospective/Retrospective
Non-Interventional Cohort Study of Infliximab Naïve and
Transitioned Patients Receiving Infliximab Biosimilar SB2; 1st
Interim Analysis. UEG Week 2019. 5. Harris et al. IBD Biosimilar to
Biosimilar Infliximab Switching Study: Preliminary Results. UEG
Week 2019. 6. Remicade® is a registered trademark of Janssen
Biotech, Inc.7. Data on File: IQVIA, GERS, Insight Health ODV8.
Humira® is a registered trademark of AbbVie Biotechnology Ltd.9.
Data on File: IQVIA, (Aug 2019) GERS, Insight Health ODV
MEDIA CONTACTS:BiogenDavid
Caouette + 1 617 679 4945 public.affairs@biogen.com Samsung
Bioepis NaYun Kim+82 10 4039
799Nayun86.kim@samsung.com |
INVESTOR CONTACT:BiogenJoe Mara+1
781 464 2442IR@biogen.com |
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